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Bovine Lactoferrin Prevents Invasive Fungal Infections in Very Low Birth Weight Infants: A Randomized Controlled Trial

Lactoferrin is a glycoprotein with anti-infective activities being part of the innate defensive network. Bovine and human lactoferrin share high homology. Bovine lactoferrin can prevent late-onset sepsis in preterm very low birth weight neonates.

In preterm very low birth weight infants, bovine lactoferrin is able to prevent not only late-onset sepsis but also systemic fungal infections. This protection is achieved independently from their colonization status. (Read the full article)




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Oral Sucrose and "Facilitated Tucking" for Repeated Pain Relief in Preterms: A Randomized Controlled Trial

Preterm infants are exposed to inadequately managed painful procedures during their NICU stay, which can lead to altered pain responses. Nonpharmacologic approaches are established for the treatment of single painful procedures, but evidence for their effectiveness across time is lacking.

Oral sucrose with or without the added technique of facilitated tucking has a pain-relieving effect even in extremely premature infants undergoing repeated pain exposures; facilitated tucking alone seems to be less effective for repeated pain exposures over time. (Read the full article)




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Randomized Trial of Oral Versus Sequential IV/Oral Antibiotic for Acute Pyelonephritis in Children

The standard initial management for infants and children with acute pyelonephritis is intravenous antibiotic treatment.

Our results support the use of an oral cefixime treatment of initial episodes of acute pyelonephritis involving a gram-negative bacteria strain in children aged 1 month to 3 years who are without urological abnormalities and without clinical hemodynamic impairment. (Read the full article)




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Impaired Fetal Growth and Arterial Wall Thickening: A Randomized Trial of Omega-3 Supplementation

Impaired fetal growth is an independent risk factor for cardiovascular diseases in adulthood and is associated with arterial wall thickening, a noninvasive measure of subclinical atherosclerosis, in early childhood. No preventive strategy has been identified.

Dietary omega-3 fatty acid supplementation in early childhood prevented the association of impaired fetal growth with arterial wall thickening, suggesting that this early-life intervention may mitigate the risk of cardiovascular disease in those with impaired fetal growth. (Read the full article)




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Clinic-Integrated Behavioral Intervention for Families of Youth With Type 1 Diabetes: Randomized Clinical Trial

Strategies to assist patients in achieving optimal chronic disease self-management are critical. The complex family and regimen issues surrounding pediatric type 1 diabetes management suggest the need to integrate such strategies into routine clinical care.

This study demonstrates the efficacy of a practical, low-intensity behavioral intervention delivered during routine care for improving glycemic outcomes. Findings indicate that the approach may offer a potential model for integrating medical and behavioral sciences to improve health care. (Read the full article)




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Breast Milk and Glucose for Pain Relief in Preterm Infants: A Noninferiority Randomized Controlled Trial

Numerous late preterm infants undergo repetitive heel lancing procedures during their first hours of life to evaluate glycemic control. Heel lances are painful and 25% glucose solution is effective on reducing procedural neonatal pain scores and crying behavior.

This noninferiority randomized controlled trial demonstrated that compared with breast milk, 25% glucose provided lower pain scores and reduced duration of cry. Further research is necessary to clarify breast milk’s mechanisms and efficacy on neonatal pain relief. (Read the full article)




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A Randomized Controlled Trial of Zinc as Adjuvant Therapy for Severe Pneumonia in Young Children

Pneumonia is still a significant problem in young children from developing countries where zinc deficiency is prevalent. Although zinc supplementation reduces the risk of childhood pneumonia, the effect of adjunct zinc on severe pneumonia is unclear with conflicting results.

The overall effect, if any, of zinc as adjuvant therapy for World Health Organization–defined severe pneumonia in young children is small. (Read the full article)




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Tight Glycemic Control With Insulin in Hyperglycemic Preterm Babies: A Randomized Controlled Trial

Insulin is commonly used to treat neonatal hyperglycemia, but there are few data to support its use. Tight glycemic control with insulin improves outcome in diabetic patients, but it is not known whether it is effective in hyperglycemic preterm infants.

Tight glycemic control with insulin in hyperglycemic preterm neonates decreases the rate of linear growth despite increased weight and occipitofrontal head circumference gain and increases the risk of hypoglycemia. Insulin may not be a safe and effective treatment in hyperglycemic preterm neonates. (Read the full article)




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Randomized Trial of Probiotics and Calcium on Diarrhea and Respiratory Tract Infections in Indonesian Children

Some but not all randomized trials have shown effects of probiotics on incidence and duration of diarrhea and respiratory tract infections among children in developing countries. Calcium improves resistance to intestinal infections in adults, but efficacy in children is unknown.

Lactobacillus reuteri DSM17938 may prevent diarrhea, especially in children with lower nutritional status. Regular calcium milk, alone or with Lactobacillus casei CRL431, did not reduce diarrhea. None of the interventions affected respiratory tract infections in these Indonesian children. (Read the full article)




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Early or Delayed Enteral Feeding for Preterm Growth-Restricted Infants: A Randomized Trial

Preterm, growth-restricted infants are at high risk of necrotizing enterocolitis (NEC). NEC occurs most frequently in infants who have received enteral feeds. It is common practice to delay introduction of enteral feeds in these infants.

Early introduction of enteral feeds results in earlier achievement of full enteral feeding. Early feeding is not associated with a higher risk of NEC. Delayed feeding is associated with a higher risk of cholestasis. (Read the full article)




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Supplemental Written Information Improves Prenatal Counseling: A Randomized Trial

During prenatal counseling for prematurity, information is provided to expectant parents to empower them to participate in the medical-care decision-making regarding their child. However, numerous studies have shown that providing information effectively during preterm labor is challenging.

The current study provides evidence that effectiveness of counseling can be improved by providing written information to parents before the face-to-face verbal counseling. Appropriately presented, detailed information improves knowledge and decreases maternal anxiety. (Read the full article)




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Long-term Effectiveness of Maternal Dietary Counseling in a Low-Income Population: A Randomized Field Trial

Recent systematic reviews revealed that educational dietary interventions were effective in improving nutritional status and food consumption in the first year after birth. We are not aware, however, of studies in developing countries that have evaluated their long-term effectiveness.

This randomized trial revealed that, in a low-income population, the delivery of home-based maternal counseling focusing on breastfeeding and complementary feeding during the first year of children’s lives significantly improved the lipid profile at 7 to 8 years old. (Read the full article)




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Oral Dimenhydrinate Versus Placebo in Children With Gastroenteritis: A Randomized Controlled Trial

Dimenhydrinate, an antihistaminic agent, is a widely used drug in Canada and Europe. It limits stimulation of the vomiting center via the vestibular system. Multiple studies have shown its effectiveness in the treatment of vertigo and postoperative nausea and vomiting.

Dimenhydrinate, when given orally, did not significantly decrease the frequency of vomiting in children with acute gastroenteritis compared with placebo. The reported adverse effect proportions were similar for the dimenhydrinate and placebo groups. (Read the full article)




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Randomized Trial of Sumatriptan and Naproxen Sodium Combination in Adolescent Migraine

Treatment of adolescent migraine remains a significant unmet medical need. In adults, the combination of sumatriptan and naproxen sodium has demonstrated superior efficacy, with similar tolerability, to its components in the acute treatment of migraine.

This study constitutes the first large-scale, placebo-controlled evidence for the acute relief of adolescent migraine pain and associated symptoms with an oral medication. (Read the full article)




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Effect of Honey on Nocturnal Cough and Sleep Quality: A Double-blind, Randomized, Placebo-Controlled Study

Honey is recommended as a cough medication by the World Health Organization. To date, the efficacy of this treatment has been shown in 2 studies: one tested only buckwheat honey and the other study was not blinded.

In a randomized controlled trial, we compared 3 types of honey versus placebo as a treatment of upper respiratory tract infection–associated cough. These types of honey were superior to placebo in alleviating cough. (Read the full article)




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Effects of CPOE on Provider Cognitive Workload: A Randomized Crossover Trial

Computerized provider order entry (CPOE) has been recognized to enhance the efficiency, safety, and quality of medical work. Yet vendors and organizations have not determined best practices for customizations, resulting in systems that have poor usability and unintended consequences of use.

This study demonstrated that systematically developed order sets reduce cognitive workload and order variation in the context of improved system usability and guideline adherence. The concept of cognitive workload reduction is novel in the setting of computer order entry. (Read the full article)




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Randomized Controlled Trial of an Immunization Recall Intervention for Adolescents

Immunization recall systems have been found effective in increasing immunization rates in younger children and adults; however, there have been only a few studies in adolescents and they have produced mixed results.

In this randomized controlled trial, immunization rates were significantly higher 4 weeks after a recall intervention in which both the adolescent’s parents and the adolescent were contacted, but this effect did not persist 1 year after the intervention. (Read the full article)




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Maternal Multiple Micronutrient Supplements and Child Cognition: A Randomized Trial in Indonesia

Micronutrients are essential for brain development during gestation and infancy. Few randomized trials of maternal multiple micronutrient supplementation during pregnancy and postpartum have examined child outcomes beyond the neonatal period or tested which cognitive domains show long-term effects.

Children of undernourished mothers given multiple micronutrients performed as well as children of well-nourished mothers in motor and visual attention/spatial ability at age 42 months; children of undernourished mothers given iron/folic acid showed 4- to 5-month delays in these abilities. (Read the full article)




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Randomized Trial of Vitamin D Supplementation and Risk of Acute Respiratory Tract Infection in Mongolia

A growing number of epidemiologic studies suggest that individuals with lower vitamin D levels are at higher risk of acute respiratory tract infection. Randomized controlled trials are needed to determine if vitamin D supplementation would decrease this risk.

In a randomized controlled trial of 247 Mongolian children with vitamin D deficiency in winter, with double-blinding and 99% follow-up, vitamin D supplementation significantly reduced the risk of acute respiratory tract infections. (Read the full article)




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Cobedding and Recovery Time After Heel Lance in Preterm Twins: Results of a Randomized Trial

Skin-to-skin contact with mothers and fathers has been associated with lower pain reactivity and enhanced physiologic recovery after heel lance. The effect of skin-to-skin contact between preterm twins during cobedding on pain response has yet to be studied.

We demonstrate that cobedding significantly diminished time to recovery in preterm twins after heel lance but did not lower pain reactivity. (Read the full article)




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Postnatal Fish Oil Supplementation in High-Risk Infants to Prevent Allergy: Randomized Controlled Trial

Declining dietary omega 3 polyunsaturated fatty acids has been associated with rising allergy prevalence and fish oil is therefore of interest in allergy prevention. Supplementation during pregnancy, but not after the age of 6 months, has achieved some allergy reductions.

We assessed the effect of fish oil supplementation from birth to 6 months, which has not been investigated previously. Our results, together with previous findings, will likely help define a "window of opportunity" for allergy intervention using fish oil supplements. (Read the full article)




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Five-Year Follow-up of Harms and Benefits of Behavioral Infant Sleep Intervention: Randomized Trial

Behavioral techniques effectively reduce infant sleep problems and associated maternal depression in the short- to medium-term (4–16 months’ postintervention). Despite their effectiveness, theoretical concerns persist about long-term harm on children’s emotional development, stress regulation, mental health, and the child-parent relationship.

Behavioral sleep techniques did not cause long-lasting harms or benefits to child, child-parent, or maternal outcomes. Parents and health professionals can feel comfortable about using these techniques to reduce the population burden of infant sleep problems and maternal depression. (Read the full article)




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Randomized Trial of Prongs or Mask for Nasal Continuous Positive Airway Pressure in Preterm Infants

Nasal continuous positive airway pressure (NCPAP) is commonly given to premature infants with nasal prongs and nasal masks. Prongs and masks appear to injure the nose of preterm infants with equal frequency.

Nasal masks are more effective than nasal prongs for preventing intubation and mechanical ventilation in premature infants within 72 hours of starting NCPAP. (Read the full article)




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Growth and Fat-Free Mass Gain in Preterm Infants After Discharge: A Randomized Controlled Trial

Postnatal growth restriction of preterm infants is a universal problem. Early "catch-up growth" has been associated with development of metabolic syndrome. In addition, preterm infants appear to be at major risk for developing increased adiposity and insulin resistance.

The consumption of a nutrient-enriched formula after hospital discharge may be beneficial in adequate for gestational age infants both in terms of head circumference growth and fat-free mass gain. (Read the full article)




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Long-term Benefits of Home-based Preventive Care for Preterm Infants: A Randomized Trial

Randomized controlled trials of early developmental interventions for very preterm infants demonstrate short-term benefits for infant neurobehavioral functioning. The longer-term benefits of these interventions for children and their families are not yet clear.

This randomized trial shows that home-based preventive care over the first year of life for very preterm infants has selective long-term benefits. Caregivers report less anxiety and fewer were at risk for an anxiety disorder. Preschoolers show fewer internalizing behaviors. (Read the full article)




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Office-Based Randomized Controlled Trial to Reduce Screen Time in Preschool Children

Interventions to reduce screen time in preschool-aged children are promising.

A screen time intervention in 3-year-old children implemented in the primary care setting did not reduce screen time or BMI. (Read the full article)




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A Randomized Placebo-Controlled Trial of Massage Therapy on the Immune System of Preterm Infants

Stressful events adversely affect the immune system, particularly the natural killer (NK) cells. Infants in the NICUs are exposed to stressful stimuli. The effect of massage therapy on the immune system of preterm infants has not been investigated.

This randomized placebo-controlled study found daily massage performed in stable preterm infants for a minimum of 5 days was associated with an increase in NK cell cytotoxicity despite lower absolute NK cell numbers compared with controls. (Read the full article)




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Timing of the Introduction of Complementary Foods in Infancy: A Randomized Controlled Trial

In a previous randomized trial, infants from a low-resource country exclusively breastfed for 6 months had lower iron stores at 6 months compared with breastfeeding infants receiving solid foods. Randomized trials of exclusive breastfeeding in high-income countries are lacking.

In a high-income country, infants who receive complementary foods in addition to breast milk from 4 months of age had higher iron stores at 6 months compared with those exclusively breastfed for 6 months. (Read the full article)




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Breastfeeding Education and Support Trial for Overweight and Obese Women: A Randomized Trial

Obesity is a risk factor for failure to initiate breastfeeding, formula supplementation, and short breastfeeding duration. There is a need for interventions that can improve the breastfeeding outcomes of overweight and obese women.

Breastfeeding peer counseling targeting overweight/obese women did not affect exclusive breastfeeding rates or breastfeeding continuation beyond 2 weeks. However, the intervention was associated with improvements in early breastfeeding intensity and fewer infant hospitalizations in the first 6 months after birth. (Read the full article)




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Near-Infrared Imaging in Intravenous Cannulation in Children: A Cluster Randomized Clinical Trial

Gaining intravenous access in children can be difficult. Recently, several near-infrared devices have been introduced attempting to support intravenous cannulation by visualizing veins underneath skin. Only one of those devices has been evaluated systemically thus far and results are inconclusive.

Although it was possible to visualize veins with near-infrared in most patients, the VascuLuminator did not improve the success of cannulation. An explanation is that the main problem is probably not localization of the vein but insertion of the cannula. (Read the full article)




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Subclinical Cerebral Edema in Children With Diabetic Ketoacidosis Randomized to 2 Different Rehydration Protocols

Cerebral edema (CE) occurs frequently during treatment of diabetic ketoacidosis (DKA) in children. Severe, life-threatening CE occurs rarely, but subclinical CE is common. Whether the rate of infusion of intravenous fluids influences the occurrence or severity of CE is unknown.

This study demonstrates that the rate of fluid infusion in children with DKA does not substantially affect MRI measures of CE. Studies assessing measures other than edema formation are necessary to determine whether fluid infusion rates influence DKA-related brain injury. (Read the full article)




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A Randomized Trial of Stylets for Intubating Newborn Infants

Endotracheal intubation of newborn infants is a common procedure. Competency in this skill is mandatory for many pediatric training programs. The safety and benefits of using a stylet for intubating newborn infants are unknown.

Pediatric trainees are commonly unsuccessful at performing endotracheal intubation. Adverse events of using a stylet are uncommon. The use of a stylet does not increase success rates. (Read the full article)




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A Randomized Clinical Trial of a Web-Based Tobacco Cessation Education Program

Children exposed to second-hand smoke have high rates of hospitalization for respiratory illness. These visits represent a "teachable moment" when parental smokers can be motivated to quit. However, pediatric health care practitioners receive little training in tobacco cessation.

The Web-Based Respiratory Education About Tobacco and Health online training program was effective at increasing the provision of an effective tobacco cessation intervention by pediatric hospital-based respiratory therapists, registered nurses, and nurse practitioners to adult smokers. (Read the full article)




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Randomized Trial of Iron Supplementation versus Routine Iron Intake in VLBW Infants

The American Academy of Pediatrics recommends that infants <1500 g birth weight receive an iron intake of 4 mg/kg per day. There are no randomized trials to support this recommendation.

This trial compared the effect of iron supplementation of 2 mg/kg per day on the hematocrit at 36 weeks' postmenstrual age. This study concluded that iron supplementation does not affect the 36-week hematocrit or the number of transfusions in infants <1500 g. (Read the full article)




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Nine-Year Follow-up of a Home-Visitation Program: A Randomized Trial

A number of studies have shown that home-visiting interventions can improve outcomes for children being raised in families that face multiple adversities. It is less clear how well these benefits are sustained over long periods.

The current study shows that the Early Start program of home visitation has benefits in terms of reducing child abuse, increasing parental competence, and improving childhood behavioral adjustment for up to 9 years, suggesting long-term benefits of home visitation. (Read the full article)




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Surfactant Administration via Thin Catheter During Spontaneous Breathing: Randomized Controlled Trial

A policy of intubation, mechanical ventilation, and surfactant administration is commonly used for the treatment of respiratory distress syndrome worldwide; however subsequent development of bronchopulmonary dysplasia remains as risk with this standard approach.

Noninvasive surfactant administration technique during spontaneous breathing (Take Care) along with nasal continuous positive airway pressure support successfully reduces the need for further respiratory support and bronchopulmonary dysplasia rate in very low birth weight infants. (Read the full article)




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Modifying Media Content for Preschool Children: A Randomized Controlled Trial

Children have been shown to imitate behaviors they see on screen.

Modifying what children watch can improve their observed behavior. (Read the full article)




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A Parent-Focused Intervention to Reduce Infant Obesity Risk Behaviors: A Randomized Trial

While obesity-promoting eating, sedentary and physical activity behaviors, and increased prevalence of adiposity are evident from early life, few high-quality studies have evaluated interventions that seek to influence the development of these behaviors in very early childhood.

This study highlights the receptivity of first-time parents to interventions focused on their new infant’s eating and active play and provides evidence of effectiveness on some obesity-promoting behaviors in very early childhood. (Read the full article)




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Heliox Therapy in Bronchiolitis: Phase III Multicenter Double-Blind Randomized Controlled Trial

Bronchiolitis, a leading cause of infant hospitalization, has few proven treatments. A few small studies have reported the beneficial effects of a mixture of 21% oxygen + 79% helium (Heliox). The 2010 Cochrane Review concluded that additional large randomized controlled trials were needed to determine the therapeutic role of Heliox in bronchiolitis.

The Bronchiolitis Randomized Controlled Trial Emergency-Assisted Therapy with Heliox—An Evaluation (BREATHE) trial is the largest multicenter randomized controlled trial to date to investigate the efficacy of Heliox in acute bronchiolitis. The delivery method for Heliox therapy was found to be crucial to its efficacy. (Read the full article)




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Chlorhexidine Cleansing of the Umbilical Cord and Separation Time: A Cluster-Randomized Trial

Chlorhexidine cleansing of the cord can reduce mortality in high-risk settings. Time to separation may increase with topical applications of chlorhexidine; 1 previous community trial quantified this increase and did not measure whether caretakers perceived the delay.

Single and multiple cleansing of the umbilical cord increases time to separation by ~50%, or an average of 2 to 2.5 days. Caretakers were able to detect this difference and expressed dissatisfaction, while still accepting the intervention. (Read the full article)




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A Cough Algorithm for Chronic Cough in Children: A Multicenter, Randomized Controlled Study

Parents of children with chronic cough have poor quality of life and often seek multiple consultations. There are few randomized controlled trials on the management of cough or on the efficacy of management algorithms outside of inpatient settings.

In a multicenter, trial, we found that the management of children with chronic cough, in accordance with a standardized algorithm, improves clinical outcomes. Earlier application of the algorithm leads to earlier cough resolution and improved parental quality of life. (Read the full article)




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A Randomized, Masked, Placebo-Controlled Study of Darbepoetin Alfa in Preterm Infants

Preterm infants in the NICU receive the greatest number of transfusions of any patient population. The administration of the long-acting erythropoiesis stimulating agent (ESA) darbepoetin to reduce or eliminate transfusions in preterm infants has not been evaluated.

Infants receiving ESAs received half the number of transfusions and were exposed to approximately half the donors compared with the placebo group. More than half of the ESA recipients (59% darbepoetin recipients, 52% erythropoietin recipients) remained untransfused during their hospitalization. (Read the full article)




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A Randomized Trial of Exothermic Mattresses for Preterm Newborns in Polyethylene Bags

Wrapping very preterm newborns in polyethylene bags in the delivery room reduces hypothermia on admission to the NICU, but many infants remain cold despite their use. Placing polyethylene-wrapped infants on exothermic mattresses may reduce hypothermia but increase hyperthermia.

Placing polyethylene-wrapped very preterm infants on exothermic mattresses in the delivery room results in more infants with abnormal temperature and more hyperthermia on admission to the NICU. (Read the full article)




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Randomized Controlled Trial of a Car Safety Seat Insert to Reduce Hypoxia in Term Infants

Brief periods of low oxygen saturation are common in infants while restrained in car safety seats. There is some evidence that an insert that allows the infant head to rest in a neutral position in sleep may reduce hypoxic episodes.

This randomized controlled study shows that the insert reduced numbers of obstructive apneas and the severity of desaturation events but did not significantly reduce the overall rate of moderate desaturations. (Read the full article)




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Mask Versus Nasal Tube for Stabilization of Preterm Infants at Birth: A Randomized Controlled Trial

Effective ventilation is fundamental to successful resuscitation of newborns, but face mask leak and airway obstruction are common during manual positive-pressure ventilation in the delivery room, which may compromise resuscitation.

Compared with a soft, round silicone face mask, using a nasal tube to provide respiratory support in the delivery room does not reduce the rate of intubation but may be a suitable alternative with equivocal efficacy. (Read the full article)




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A Randomized Trial of Nasal Prong or Face Mask for Respiratory Support for Preterm Newborns

Respiratory support is commonly given to newborn infants via a face mask in the delivery room. Respiratory support given to preterm infants via a single nasal prong may be more effective.

Compared with a face mask, using a single nasal prong to deliver respiratory support to preterm newborns did not result in less intubation and ventilation in the delivery room. (Read the full article)




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Two-Year Outcomes of a Randomized Controlled Trial of Inhaled Nitric Oxide in Premature Infants

Bronchopulmonary dysplasia is associated with increased long-term neurodevelopmental and respiratory morbidity. Inhaled nitric oxide given to reduce morbidity in very preterm infants does not reduce the prevalence of bronchopulmonary dysplasia and has uncertain effects on long-term outcome.

Inhaled nitric oxide (5 ppm) given early in the course of respiratory illness in infants born before 29 weeks of gestation is not associated with changes in developmental or respiratory outcomes at 2 years of age corrected for prematurity. (Read the full article)




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Use of a Computerized Decision Aid for ADHD Diagnosis: A Randomized Controlled Trial

Despite the existence of authoritative guidelines to assist primary care physicians in identifying and managing attention-deficit/hyperactivity disorder (ADHD), ample evidence demonstrates that they continue to diagnose and treat this disorder suboptimally.

The introduction of a clinical decision support module resulted in higher quality of care with respect to ADHD diagnosis including a prospect for higher quality of ADHD management in children. (Read the full article)




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Screening Strategies for Hip Dysplasia: Long-term Outcome of a Randomized Controlled Trial

Only 2 randomized controlled trials have addressed effects of ultrasound screening for developmental hip dysplasia. Both concluded that adding universal or selective ultrasound to routine clinical examination gave a nonsignificant reduction in rates of late presenting cases, but higher treatment rates.

This maturity review assesses long-term outcome of one of these trials. Rates of radiographic findings indicating acetabular dysplasia and degenerative change were similar across the 3 screening groups in young adulthood. Increased treatment rates were not associated with avascular necrosis. (Read the full article)




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Randomized Trial of Plastic Bags to Prevent Term Neonatal Hypothermia in a Resource-Poor Setting

Term neonates in resource-poor settings frequently develop hypothermia. Plastic bags or wraps are a low-cost intervention for the prevention of hypothermia in preterm and low birth weight infants that may also be effective in term infants.

For term neonates born in a resource-poor health facility, placement in a plastic bag at birth can reduce the incidence of hypothermia at 1 hour after birth. (Read the full article)