Management of late-preterm and term infants with hyperbilirubinaemia in resource-constrained settings.

Hyperbilirubinaemia is a ubiquitous transitional morbidity in the vast majority of newborns and a leading cause of hospitalisation in the first week of life worldwide. While timely and effective phototherapy and exchange transfusion are well proven treatments for severe neonatal hyperbilirubinaemia, inappropriate or ineffective treatment of hyperbilirubinaemia, at secondary and tertiary hospitals, still prevails in many poorly-resourced countries accounting for a disproportionately high burden of bilirubin-induced mortality and long-term morbidity. As part of the efforts to curtail the widely reported risks of frequent but avoidable bilirubin-induced neurologic dysfunction (acute bilirubin encephalopathy (ABE) and kernicterus) in low and middle-income countries (LMICs) with significant resource constraints, this article presents a practical framework for the management of late-preterm and term infants (≥ 35 weeks of gestation) with clinically significant hyperbilirubinaemia in these countries particularly where local practice guidelines are lacking. Standard and validated protocols were followed in adapting available evidence-based national guidelines on the management of hyperbilirubinaemia through a collaboration among clinicians and experts on newborn jaundice from different world regions. Tasks and resources required for the comprehensive management of infants with or at risk of severe hyperbilirubinaemia at all levels of healthcare delivery are proposed, covering primary prevention, early detection, diagnosis, monitoring, treatment, and follow-up. Additionally, actionable treatment or referral levels for phototherapy and exchange transfusion are proposed within the context of several confounding factors such as widespread exclusive breastfeeding, infections, blood group incompatibilities and G6PD deficiency, which place infants at high risk of severe hyperbilirubinaemia and bilirubin-induced neurologic dysfunction in LMICs, as well as the limited facilities for clinical investigations and inconsistent functionality of available phototherapy devices. The need to adjust these levels as appropriate depending on the available facilities in each clinical setting and the risk profile of the infant is emphasised with a view to avoiding over-treatment or under-treatment. These recommendations should serve as a valuable reference material for health workers, guide the development of contextually-relevant national guidelines in each LMIC, as well as facilitate effective advocacy and mobilisation of requisite resources for the optimal care of infants with hyperbilirubinaemia at all levels

Impact of Optimized Breastfeeding on the Costs of Necrotizing Enterocolitis in Extremely Low Birthweight Infants

To estimate risk of NEC for ELBW infants as a function of preterm formula and maternal milk (MM) intake and calculate the impact of suboptimal feeding on NEC incidence and costs

Skinfold Thickness in North American Infants 24-41 Weeks Gestation

Weight, length, head circumference, skinfold thickness (triceps, biceps, subscapular, abdominal), and arm circumference were obtained within 72 hours of birth from 642 singleton, Caucasian infants born at 24-41 weeks gestation in Tucson, Arizona. Birthweights for term and preterm infants were similar to those reported for a comparable sea level population.From 24 to 41 weeks gestation skinfold thickness (SFT) increased at all sites from an average of 1.0 mm to 3.4 mm; arm circumference doubled; mid-arm cross- sectional fat area increased from 12 to 18 percent of the total cross-sectional mid­arm area; and the ratio of arm circumference/head circumference rose from 0.23 to 0.31. SFT measurements at the four sites were highly intercorrelated and without evidence of lateralization at birth. The rate of fat deposition, as assessed by change in median SFT, rose rapidly after 32 weeks gestation, peaking at 38-39 weeks and declining thereafter. These data may be helpful in determining nutritional status at birth and assessing postnatal growth of term and preterm North American infants

Inter- and Intra-Observer Reliability of Skinfold Thickness Measurements in Newborn Infants

Inter-observer and intra-observer reliability in obtaining skinfold thickness measurements on newborn infants were examined. As part of ongoing growth studies,20 duplicate sets of eight skinfolds were measured by an index observer and one of three other experienced anthropometrists. Additionally, ten sets of duplicate measurements were obtained several hours apart by the index observer. No consistent biases among the four observers were noted, although occasional differences at the arm sites were observed. Although the technical errors of measurement were smaller, the coefficients of variation were of the same magnitude as those previously reported for skinfold measurements in older children. Intra-observer variation was markedly less than inter-observer variation for all sites. To minimize intra-observer bias, skinfold thickness measurements should be obtained at multiple rather than single sites. The data also suggest measurement error will be minimized by using a single observer for longitudinal, and multiple observers for cross-sectional studies

Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.

ObjectiveExtremely low birth weight children are at high risk for cognitive impairment.Study designCognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.ResultHigher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.ConclusionPoor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants

Developmental scores at 1 year with increasing gestational age, 37-41 weeks

OBJECTIVE: To examine the relationship between gestational age and mental and psychomotor development scores in healthy infants born between 37 and 41 weeks. METHODS: The cohort included 1562 participants enrolled during infancy in an iron deficiency anemia preventive trial in Santiago, Chile. All participants were healthy, full-term (37-41 weeks) infants who weighed 3 kg or more at birth. Development at 12 months was assessed using the Bayley Scales of Infant Development. Using generalized linear modeling, we analyzed the association between gestational age and 1-year-old developmental status, taking into account potential confounders including birth weight percentile, gender, socioeconomic status, the home environment, iron status, and iron supplementation. RESULTS: For each additional week of gestation, the Mental Development Index increased by 0.8 points (95% confidence interval = 0.2-1.4), and the Psychomotor Development Index increased by 1.4 points (95% confidence interval = 0.

Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial

Abstract Background Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT. Methods/design This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 μW/cm2/nm. Primary outcome: FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT. Conclusion This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to (reliable) CPT in the tropics. Trial registration ClinicalTrials.gov Identifier: NCT0143481

Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial

BACKGROUND: Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries, particularly in sub-Saharan Africa. The standard treatment for jaundice using conventional phototherapy (CPT) with electric artificial blue light sources is often hampered by the lack of (functional) CPT devices due either to financial constraints or erratic electrical power. In an attempt to make phototherapy (PT) more readily available for the treatment of pathologic jaundice in underserved tropical regions, we set out to test the hypothesis that filtered sunlight phototherapy (FS-PT), in which potentially harmful ultraviolet and infrared rays are appropriately screened, will be as efficacious as CPT. METHODS/DESIGN: This prospective, non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin (TSB, defined as 3 mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT) who will be randomly and equally assigned to receive FS-PT or CPT for a total of 616 days at an inner-city maternity hospital in Lagos, Nigeria. Two FS-PT canopies with pre-tested films will be used. One canopy with a film that transmits roughly 33% blue light (wavelength range: 400 to 520 nm) will be used during sunny periods of a day. Another canopy with a film that transmits about 79% blue light will be used during overcast periods of the day. The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above 8 μW/cm(2)/nm. Primary outcome: FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels. Secondary outcome: The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT. CONCLUSION: This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to (reliable) CPT in the tropics. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0143481

Filtered sunlight versus intensive electric powered phototherapy in moderate-to-severe neonatal hyperbilirubinaemia: a randomised controlled non-inferiority trial

Summary: Background: Kernicterus resulting from severe neonatal hyperbilirubinaemia is a leading cause of preventable deaths and disabilities in low-income and middle-income countries, partly because high-quality intensive phototherapy is unavailable. Previously, we showed that filtered-sunlight phototherapy (FSPT) was efficacious and safe for treatment of mild-to-moderate neonatal hyperbilirubinaemia. We aimed to extend these studies to infants with moderate-to-severe hyperbilirubinaemia. Methods: We did a prospective, randomised controlled non-inferiority trial in Ogbomoso, Nigeria—a simulated rural setting. Near-term or term infants aged 14 days or younger who were of 35 weeks or more gestational age and with total serum bilirubin concentrations at or above the recommended age-dependent treatment levels for high-risk neonates were randomly assigned (1:1) to either FSPT or intensive electric phototherapy (IEPT). Randomisation was computer-generated, and neither clinicians nor the parents or guardians of participants were masked to group allocation. FSPT was delivered in a transparent polycarbonate room lined with commercial tinting films that transmitted effective phototherapeutic light, blocked ultraviolet light, and reduced infrared radiation. The primary outcome was efficacy, which was based on assessable treatment days only (ie, those on which at least 4 h of phototherapy was delivered) and defined as a rate of increase in total serum bilirubin concentrations of less than 3·4 μmol/L/h in infants aged 72 h or younger, or a decrease in total serum bilirubin concentrations in those older than 72 h. Safety was defined as no sustained hypothermia, hyperthermia, dehydration, or sunburn and was based on all treatment days. Analysis was by intention to treat with a non-inferiority margin of 10%. Findings: Between July 31, 2015, and April 30, 2017, 174 neonates were enrolled and randomly assigned: 87 to FSPT and 87 to IEPT. Neonates in the FSPT group received 215 days of phototherapy, 82 (38%) of which were not assessable. Neonates in the IEPT group received 219 treatment days of phototherapy, 67 (31%) of which were not assessable. Median irradiance was 37·3 μW/cm2/nm (IQR 21·4–56·4) in the FSPT group and 50·4 μW/cm2/nm (44·5–66·2) in the IEPT group. FSPT was efficacious on 116 (87·2%) of 133 treatment days; IEPT was efficacious on 135 (88·8%) of 152 treatment days (mean difference −1·6%, 95% CI −9·9 to 6·7; p=0·8165). Because the CI did not extend below −10%, we concluded that FSPT was not inferior to IEPT. Treatment was safe for all neonates. Interpretation: FSPT is safe and no less efficacious than IEPT for treatment of moderate-to-severe neonatal hyperbilirubinaemia in near-term and term infants. Funding: Thrasher Research Fund and National Center for Advancing Translational Sciences