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1.
JAMA Netw Open ; 7(7): e2416870, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38949814

ABSTRACT

Importance: Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known. Objective: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial. Design, Setting, and Participants: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years. Intervention: UCM and ECC. Main Outcomes and Measures: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used. Results: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86). Conclusions and Relevance: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns. Trial Registration: ClinicalTrials.gov Identifier: NCT03631940.


Subject(s)
Umbilical Cord Clamping , Humans , Female , Infant, Newborn , Male , Infant , Umbilical Cord Clamping/methods , Cross-Over Studies , Umbilical Cord , Hypoxia-Ischemia, Brain/therapy , Child, Preschool
2.
Pediatrics ; 152(6)2023 Dec 01.
Article in English | MEDLINE | ID: mdl-37941523

ABSTRACT

OBJECTIVES: To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS: Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS: Among 1019 infants (UCM n = 511 and DCC n = 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (-1.4% to 1.4%), P = .99). CONCLUSIONS: In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks' gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.


Subject(s)
Infant, Premature , Umbilical Cord Clamping , Infant, Newborn , Humans , Female , Infant , Pregnancy , Male , Umbilical Cord/surgery , Placenta , Gestational Age , Cerebral Hemorrhage/etiology , Constriction
3.
J Clin Med ; 12(3)2023 Feb 03.
Article in English | MEDLINE | ID: mdl-36769876

ABSTRACT

Retinopathy of prematurity (ROP) is a leading cause of childhood blindness. Not only do the epidemiologic determinants and distributions of patients with ROP vary worldwide, but clinical differences have also been described. The Third Edition of the International Classification of ROP (ICROP3) acknowledges that aggressive ROP (AROP) can occur in larger preterm infants and involve areas of the more anterior retina, particularly in low-resource settings with unmonitored oxygen supplementation. As sub-specialty training programs are underway to address an epidemic of ROP in sub-Saharan Africa, recognizing characteristic retinal pathology in preterm infants exposed to unmonitored supplemental oxygen is important to proper diagnosis and treatment. This paper describes specific features associated with various ROP presentations: oxygen-induced retinopathy in animal models, traditional ROP seen in high-income countries with modern oxygen management, and ROP related to excessive oxygen supplementation in low- and middle-income countries: oxygen-associated ROP (OA-ROP).

4.
Am J Obstet Gynecol ; 228(2): 217.e1-217.e14, 2023 02.
Article in English | MEDLINE | ID: mdl-35970202

ABSTRACT

BACKGROUND: Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.


Subject(s)
Infant, Newborn, Diseases , Umbilical Cord Clamping , Umbilical Cord , Female , Humans , Infant, Newborn , Pregnancy , Blood Transfusion , Constriction , Cross-Over Studies , Hemoglobins , Hypoxia-Ischemia, Brain/etiology , Infant, Premature , Placenta , Umbilical Cord/surgery , Umbilical Cord Clamping/methods , Infant, Premature, Diseases/surgery , Infant, Premature, Diseases/therapy , Infant, Newborn, Diseases/surgery , Infant, Newborn, Diseases/therapy
5.
BMC Pediatr ; 21(1): 145, 2021 03 25.
Article in English | MEDLINE | ID: mdl-33765972

ABSTRACT

Early discharge of preterm very low birth weight (VLBW) infants is at times inevitable in low resource settings. The implication of such practice on the growth of this high-risk population is not known. We conducted a retrospective chart review to describe the growth of preterm VLBW infants discharged with a weight of less than 1500 g. OBJECTIVES: To describe the growth of discharged preterm VLBW infants over the first 12 weeks. METHOD: Between June 2013 and January 2014; 164 discharged preterm VLBW infants were followed up for 3 months. Among the survivors (132), we identified 111 infant records for this study. Relevant data was entered in STATA for analysis. Growth percentiles were determined at approximately 4 weeks, 8 weeks, and 12 weeks post-discharge using the intergrowth 21st growth charts. Growth velocities were computed using the 2-point average weight model. Regression analysis was used to identify factors associated with growth failure. Growth failure was defined as occipital frontal circumference (OFC), weight, and length < 10th centile by 12 weeks post-discharge. P-value of < 0.05 was considered significant at a 95% confidence interval. RESULTS: Among the study infants the median gestational age and weight at birth were 32 weeks (range 28-35 weeks) and 1250 g(range 850-1500 g) respectively; 60/111(54%) were Small for Gestational Age (SGA). The median discharge postmenstrual age (PMA) was 34 weeks (range 30-38 weeks) and weight was 1140 g (range 830-1490 g). The majority 88.2% had not recovered birth weight at discharge of whom 59.1% recovered by 2 weeks and 40.9% recovered between 2 and 4 weeks after discharge. By 12 weeks post-discharge the median PMA and weight were 46 weeks (range 37-51 weeks),and 3110 g (range 1750-5000 g) respectively, 38.7% of the infants had growth failure and 36.9% had OFC <3rd centile. Growth velocity < 15 g/kg/d in the first 4 weeks (OR 3.8, p 0.010) and subsequent 4 weeks (OR 2.5, p 0.049) post-discharge were independently associated with growth failure. CONCLUSION: Slow birth weight recovery was observed and growth failure was prevalent by 12 weeks post-discharge with more than a third having severe microcephaly. Poor post-discharge growth velocity was associated with subsequent growth failure. RECOMMENDATIONS: Growth velocity monitoring among preterm VLBW infants should be emphasized. The implication and interventions of this early growth failure needs to be explored.


Subject(s)
Aftercare , Patient Discharge , Birth Weight , Humans , Infant , Infant, Newborn , Infant, Premature , Infant, Very Low Birth Weight , Retrospective Studies
6.
J Perinatol ; 41(11): 2631-2638, 2021 11.
Article in English | MEDLINE | ID: mdl-33772113

ABSTRACT

OBJECTIVES: To provide more comprehensive data on the management of oxygen supplementation in neonates in sub-Saharan Africa. STUDY DESIGN: An online survey on the management of oxygen supplementation for infants in neonatal units was sent to 278 healthcare personnel in sub-Saharan Africa. RESULTS: One hundred and nine responses from 82 neonatal care units in 54% (26/48) sub-Saharan African countries were received. All units had the capacity to provide oxygen supplementation. However, only 50% (38/76) had access to blend oxygen with medical air and 1% (1/75) had the capacity to blend oxygen/air for every infant. Although 96% (72/75) of units could monitor oxygen saturation, monitoring was mostly intermittent and only 32% (24/75) were able to monitor oxygen saturation in every infant receiving oxygen supplementation. CONCLUSIONS: Findings indicate that oxygen supplementation is inadequately managed in neonatal units in sub-Saharan Africa, which may put infants at risk of developing severe ROP.


Subject(s)
Oxygen Inhalation Therapy , Oxygen , Africa South of the Sahara , Cross-Sectional Studies , Humans , Infant , Infant, Newborn , Surveys and Questionnaires
8.
Paediatr Int Child Health ; 40(1): 7-10, 2020 02.
Article in English | MEDLINE | ID: mdl-31875773

ABSTRACT

Abbreviations: ABE: acute bilirubin encephalopathy; ABR: auditory evoked brainstem response; BIND: bilirubin-induced neurological dysfunction; EBT: exchange blood transfusions; HIC: high-income countries; KSD: kernicterus spectrum disorder; LED: light-emitting diode; LMIC: low- and middle-income countries; SNH: severe neonatal jaundice or hyperbilirubinaemia; TcB: transcutaneous bilirubinometry; TSB: total serum bilirubin.


Subject(s)
Jaundice, Neonatal , Kernicterus , Bilirubin , Developing Countries , Humans , India , Infant, Newborn , Neonatal Screening
9.
JAMA ; 322(19): 1877-1886, 2019 11 19.
Article in English | MEDLINE | ID: mdl-31742630

ABSTRACT

Importance: Umbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation. Objective: To determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping. Design, Setting, and Participants: Noninferiority randomized clinical trial of preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018. Interventions: Participants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238). Main Outcomes and Measures: The primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin. Results: Among 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, -2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks' gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002). Conclusions and Relevance: In this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks' gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulting post hoc nature of the analyses preclude definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT03019367.


Subject(s)
Cerebral Intraventricular Hemorrhage/prevention & control , Constriction , Infant, Premature, Diseases/prevention & control , Infant, Premature , Umbilical Cord , Early Termination of Clinical Trials , Female , Gestational Age , Humans , Infant , Infant Death , Infant, Newborn , Infant, Premature, Diseases/mortality , Male , Outcome Assessment, Health Care , Pregnancy
10.
J Perinatol ; 39(11): 1546-1554, 2019 11.
Article in English | MEDLINE | ID: mdl-31431654

ABSTRACT

OBJECTIVE: Extremely low birth weight children are at high risk for cognitive impairment. STUDY DESIGN: Cognitive 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. RESULT: Higher 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. CONCLUSION: Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.


Subject(s)
Cognition Disorders/epidemiology , Family , Infant, Extremely Low Birth Weight , Social Support , Child Development , Child, Preschool , Cognition , Developmental Disabilities/epidemiology , Female , Follow-Up Studies , Humans , Infant , Infant, Newborn , Male , Regression Analysis , United States
12.
Lancet Glob Health ; 6(10): e1122-e1131, 2018 10.
Article in English | MEDLINE | ID: mdl-30170894

ABSTRACT

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.


Subject(s)
Hyperbilirubinemia, Neonatal/therapy , Phototherapy/methods , Electricity , Female , Humans , Infant, Newborn , Male , Phototherapy/adverse effects , Prospective Studies , Severity of Illness Index , Sunlight , Treatment Outcome
13.
BMC Pediatr ; 18(1): 239, 2018 07 21.
Article in English | MEDLINE | ID: mdl-30031387

ABSTRACT

BACKGROUND: Early discharge of very low birth weight infant (VLBW) in low resource settings is inevitable but to minimize mortality of these infants after discharge we need to identify the death attributes. METHOD: A prospective cohort was conducted among 190 VLBW infants discharged from Mulago Special Care Baby Unit (SCBU) with discharge weight of < 1500 g over an 8 months period. These infants were followed up with the aims of determining the proportion dead 3 months after discharge, identifying factors associated and possible causes of death. Relevant data were captured, transferred in to STATA and imported to SPSS 12.0.1 for analysis. To determine factors associated with mortality bi-variable and multivariable regressions were conducted. A p-value of < 0.05 was considered significant and 95% confidence interval was used. RESULTS: Of the enrolled infants 164 (86.3%) completed follow up. The median gestational age of study participants was 32 weeks (range 26-35 weeks), the mean discharge weight was 1119 g (range 760-1470 g), and 59.8% were small for gestational age (SGA). During follow up 32 (19.5%) infants died. Infants discharged with weight of < 1200 g accounted for 81.2% of the deaths. Majority of the deaths (68.7%) occurred in the first month after discharge. Factors independently associated with mortality were discharge weight < 1000 g (OR 3.10, p 0.015) and not being SGA (OR 3.54, p 0.019). The main causes of death were presumed sepsis 50.0% and suspected cot death (25.0%). CONCLUSION: Mortality after hospital discharge among VLBW infants is high. Discharge at weight < 1200 g may not be a safe practice. Measures to prevent sepsis and suspected cot death should be addressed prior to considering early discharge of these infants.


Subject(s)
Developing Countries/statistics & numerical data , Infant Mortality , Infant, Very Low Birth Weight , Birth Weight , Female , Gestational Age , Humans , Infant , Infant, Newborn , Infant, Premature , Male , Patient Discharge , Prospective Studies , Sepsis/mortality , Sudden Infant Death , Uganda/epidemiology , Weight Gain
14.
Pediatrics ; 142(1)2018 07.
Article in English | MEDLINE | ID: mdl-29945955

ABSTRACT

BACKGROUND AND OBJECTIVES: Children born extremely preterm are at risk for cognitive difficulties and disability. The relative prognostic value of neonatal brain MRI and cranial ultrasound (CUS) for school-age outcomes remains unclear. Our objectives were to relate near-term conventional brain MRI and early and late CUS to cognitive impairment and disability at 6 to 7 years among children born extremely preterm and assess prognostic value. METHODS: A prospective study of adverse early and late CUS and near-term conventional MRI findings to predict outcomes at 6 to 7 years including a full-scale IQ (FSIQ) <70 and disability (FSIQ <70, moderate-to-severe cerebral palsy, or severe vision or hearing impairment) in a subgroup of Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial enrollees. Stepwise logistic regression evaluated associations of neuroimaging with outcomes, adjusting for perinatal-neonatal factors. RESULTS: A total of 386 children had follow-up. In unadjusted analyses, severity of white matter abnormality and cerebellar lesions on MRI and adverse CUS findings were associated with outcomes. In full regression models, both adverse late CUS findings (odds ratio [OR] 27.9; 95% confidence interval [CI] 6.0-129) and significant cerebellar lesions on MRI (OR 2.71; 95% CI 1.1-6.7) remained associated with disability, but only adverse late CUS findings (OR 20.1; 95% CI 3.6-111) were associated with FSIQ <70. Predictive accuracy of stepwise models was not substantially improved with the addition of neuroimaging. CONCLUSIONS: Severe but rare adverse late CUS findings were most strongly associated with cognitive impairment and disability at school age, and significant cerebellar lesions on MRI were associated with disability. Near-term conventional MRI did not substantively enhance prediction of severe early school-age outcomes.


Subject(s)
Brain/diagnostic imaging , Developmental Disabilities/diagnostic imaging , Echoencephalography/methods , Magnetic Resonance Imaging/methods , Child , Child, Preschool , Cognition , Developmental Disabilities/epidemiology , Disability Evaluation , Follow-Up Studies , Humans , Infant , Infant, Newborn , Infant, Premature , Neuroimaging/methods , Prognosis , Prospective Studies
15.
J Pediatr ; 194: 76-80, 2018 03.
Article in English | MEDLINE | ID: mdl-29246467

ABSTRACT

OBJECTIVE: To compare the effect of umbilical cord milking vs delayed cord clamping (DCC) on neurodevelopmental and health outcomes in very preterm infants at 22-26 months of corrected age. STUDY DESIGN: Neurodevelopmental outcomes at 2 years of age were assessed using the Bayley Scales of Infant Development, third edition, and a standardized neurologic examination. Data regarding pulmonary morbidities, neurosensory impairments, and hospitalizations were obtained by parental interview. Intention-to-treat was used for primary analyses. RESULTS: Of the 197 infants enrolled in the original study there were 15 deaths, 5 in the umbilical cord milking group and 10 in DCC group. Of the remaining infants, 135 (74%) were assessed at 22-26 months of corrected age. Demographics in umbilical cord milking (n = 70) and DCC (n = 65) groups were similar. Infants randomized to umbilical cord milking at birth had significantly higher cognitive and language composite scores, and were less likely to have a cognitive composite score of <85 (4% vs 15%; P = .04). Motor function was similar in both groups. There were no differences in the incidences of mild or moderate to severe neurodevelopmental impairment, hearing or visual impairments, pulmonary morbidities, or rehospitalizations between the 2 groups. CONCLUSIONS: Infants randomized to umbilical cord milking had higher language and cognitive scores compared with those randomized to DCC. There was no difference in rates of mild or moderate to severe neurodevelopmental impairment. TRIAL REGISTRATION: clinicaltrials.gov: NCT01434732.


Subject(s)
Child Development/physiology , Motor Activity/physiology , Umbilical Cord/surgery , Child, Preschool , Cognition , Cohort Studies , Female , Humans , Infant , Infant, Newborn , Infant, Premature , Male , Time Factors
16.
Pediatrics ; 139(6)2017 Jun.
Article in English | MEDLINE | ID: mdl-28562255

ABSTRACT

BACKGROUND: Behavior and socioemotional development are crucial aspects of child development . METHODS: A total of 2505 children born at <27 weeks' gestation was evaluated at 18 to 22 months' corrected age between January 1, 2008 and December 12, 2012 (86% follow-up). The Brief Infant and Toddler Social and Emotional Assessment was used to evaluate behavioral and socioemotional problems. Cognition and language were evaluated by using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Logistic regression analysis was used to evaluate for perinatal and demographic factors associated with behavioral problems (≥75th percentile) and delayed socioemotional competence (≤15th percentile). Structural equation modeling with bootstrapping was used to identify possible associated risk factors and Bayley-III scores as mediators. RESULTS: Thirty-five percent (873) of children had behavioral problems, and 26% (637) displayed deficits in socioemotional competence. Male sex, public insurance, mothers with less than a high school education, and lower maternal age were associated with behavioral problems. Deficits in competence were associated with lower birth weight, public insurance, mothers with less than a high school education, and abnormal neuromotor exam. Bayley-III language and cognitive scores were significant mediators of the relationships between risk factors and both behavioral and competence scores (P < .05). CONCLUSIONS: Extremely premature children are at risk for behavioral problems and deficits in socioemotional competence. Sociodemographic factors were associated with both socioemotional competence and behavioral problems. Deficits in socioemotional competence were also associated with neuromotor abnormalities and cognitive and language function.


Subject(s)
Child Behavior Disorders/epidemiology , Child Development , Developmental Disabilities/epidemiology , Cognition , Female , Gestational Age , Humans , Infant , Infant, Extremely Premature , Infant, Newborn , Logistic Models , Male , Risk Factors
17.
Breastfeed Med ; 11: 494-500, 2016 12.
Article in English | MEDLINE | ID: mdl-27830934

ABSTRACT

A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient.


Subject(s)
Breast Feeding/methods , Mothers , Adult , Clinical Protocols , Female , Gestational Age , Health Promotion , Humans , Infant Nutritional Physiological Phenomena , Infant, Newborn , Infant, Premature , Male , Maternal Health Services , Milk, Human , Mothers/psychology , Patient Education as Topic , Social Support
18.
Afr Health Sci ; 16(2): 347-55, 2016 Jun.
Article in English | MEDLINE | ID: mdl-27605949

ABSTRACT

OBJECTIVES: To identify reasons for neonatal admission and death with the aim of determining areas needing improvement. METHOD: A retrospective chart review was conducted on records for neonates admitted to Mulago National Referral Hospital Special Care Baby Unit (SCBU) from 1(st) November 2013 to 31(st) January 2014. Final diagnosis was generated after analyzing sequence of clinical course by 2 paediatricians. RESULTS: A total of 1192 neonates were admitted. Majority 83.3% were in-born. Main reasons for admissions were prematurity (37.7%) and low APGAR (27.9%).Overall mortality was 22.1% (Out-born 33.6%; in born 19.8%). Half (52%) of these deaths occurred in the first 24 hours of admission. Major contributors to mortality were prematurity with hypothermia and respiratory distress (33.7%) followed by birth asphyxia with HIE grade III (24.6%) and presumed sepsis (8.7%). Majority of stable at risk neonates 318/330 (i.e. low APGAR or prematurity without comorbidity) survived. Factors independently associated with death included gestational age <30 weeks (p 0.002), birth weight <1500g (p 0.007) and a 5 minute APGAR score of < 7 (p 0.001). Neither place of birth nor delayed and after hour admissions were independently associated with mortality. CONCLUSION AND RECOMMENDATIONS: Mortality rate in SCBU is high. Prematurity and its complications were major contributors to mortality. The management of hypothermia and respiratory distress needs scaling up. A step down unit for monitoring stable at risk neonates is needed in order to decongest SCBU.


Subject(s)
Critical Care/methods , Health Resources/economics , Health Services Needs and Demand , Infant Mortality/trends , Referral and Consultation/economics , Critical Care/economics , Developing Countries , Female , Hospitalization/statistics & numerical data , Humans , Infant , Infant Care/economics , Infant, Newborn , Intensive Care Units, Neonatal , Male , Outcome Assessment, Health Care , Poverty , Referral and Consultation/standards , Retrospective Studies , Tertiary Care Centers , Uganda
19.
J Pediatr ; 177: 108-113, 2016 10.
Article in English | MEDLINE | ID: mdl-27470688

ABSTRACT

OBJECTIVE: To evaluate whether neonates exposed to multiple intubation attempts within the first 4 days after birth have an increased incidence of intraventricular hemorrhage (IVH). STUDY DESIGN: This is a retrospective cohort study of infants intubated during the first 4 days after birth. Infants had birth weights (BWs) less than 1500 g and were admitted to the neonatal intensive care unit (NICU) at the University of California, San Diego, between January 1, 2005, and July 30, 2009. A subgroup analysis was done for infants with BW less than 750 g. RESULTS: A total of 308 infants with BW <1500 g, including 102 with a BW <750 g, were intubated within the first 4 days of life. The number of intubation attempts was significantly greater in infants with a BW <750 g who had severe IVH compared with those with mild or no IVH (OR 1.395, 95% CI 1.090-1.786, P = .008). For infants with BW <1500 g, the number of intubation attempts in the delivery room was significantly greater for infants with severe IVH (OR 1.317, 95% CI 1.052-1.649, P = .016). CONCLUSION: Increased intubation attempts were associated with increased incidence of severe IVH in infants with BW less than 750 g and in infants less than 1500 g who were intubated only in the delivery room. Prospective studies are needed to further evaluate the relationship between intubation attempts and severe IVH.


Subject(s)
Cerebral Hemorrhage/etiology , Intubation, Intratracheal/adverse effects , Cerebral Hemorrhage/epidemiology , Cohort Studies , Female , Humans , Infant, Newborn , Infant, Premature , Infant, Very Low Birth Weight , Intensive Care Units, Neonatal , Intubation, Intratracheal/statistics & numerical data , Male , Retrospective Studies , Risk
20.
N Engl J Med ; 373(12): 1115-24, 2015 Sep 17.
Article in English | MEDLINE | ID: mdl-26376136

ABSTRACT

BACKGROUND: Sequelae of severe neonatal hyperbilirubinemia constitute a substantial disease burden in areas where effective conventional phototherapy is unavailable. We previously found that the use of filtered sunlight for the purpose of phototherapy is a safe and efficacious method for reducing total bilirubin. However, its relative safety and efficacy as compared with conventional phototherapy are unknown. METHODS: We conducted a randomized, controlled noninferiority trial in which filtered sunlight was compared with conventional phototherapy for the treatment of hyperbilirubinemia in term and late-preterm neonates in a large, urban Nigerian maternity hospital. The primary end point was efficacy, which was defined as a rate of increase in total serum bilirubin of less than 0.2 mg per deciliter per hour for infants up to 72 hours of age or a decrease in total serum bilirubin for infants older than 72 hours of age who received at least 5 hours of phototherapy; we prespecified a noninferiority margin of 10% for the difference in efficacy rates between groups. The need for an exchange transfusion was a secondary end point. We also assessed safety, which was defined as the absence of the need to withdraw therapy because of hyperthermia, hypothermia, dehydration, or sunburn. RESULTS: We enrolled 447 infants and randomly assigned 224 to filtered sunlight and 223 to conventional phototherapy. Filtered sunlight was efficacious on 93% of treatment days that could be evaluated, as compared with 90% for conventional phototherapy, and had a higher mean level of irradiance (40 vs. 17 µW per square centimeter per nanometer, P<0.001). Temperatures higher than 38.0°C occurred in 5% of the infants receiving filtered sunlight and in 1% of those receiving conventional phototherapy (P<0.001), but no infant met the criteria for withdrawal from the study for reasons of safety or required an exchange transfusion. CONCLUSIONS: Filtered sunlight was noninferior to conventional phototherapy for the treatment of neonatal hyperbilirubinemia and did not result in any study withdrawals for reasons of safety. (Funded by the Thrasher Research Fund, Salt Lake City, and the National Center for Advancing Translational Sciences of the National Institutes of Health; Clinical Trials.gov number, NCT01434810.).


Subject(s)
Black People , Heliotherapy , Hyperbilirubinemia, Neonatal/therapy , ABO Blood-Group System , Bilirubin/blood , Female , Gestational Age , Heliotherapy/adverse effects , Heliotherapy/methods , Humans , Infant, Newborn , Male , Nigeria , Treatment Outcome
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