NCT04875624|Completed
Neurodevelopment of Hypoglycemic Neonates
Neurodevelopmental Outcome of Normoglycemic Versus Hypoglycemic Neonates at Risk for Hypoglycemia
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Neurodevelopmental Outcome of Normoglycemic Versus Hypoglycemic Neonates at Risk for Hypoglycemia
Sponsor study identifier
observational
126
1 country
1
Study Start
July 14, 2021
Actual (reported)Primary Completion
July 19, 2024
Actual (reported)Study Completion
July 19, 2024
Actual (reported)The investigators propose to prospectively conduct a neurodevelopmental evaluation of SGA and late preterm neonates who underwent risk-based screening for hypoglycemia at newborn nursery during the first 24 hours of life based on AAP (American Academy of Pediatrics) hypoglycemia guidelines at 18 to 24 months of age. As per internal neonatal unit protocol (reflecting AAP guidelines), all neonates at risk of hypoglycemia (all preterm infants, term infants who are SGA or LGA and IDM) are routinely screened for hypoglycemia during the first 24 hours of life via bedside point of care glucose devices (see attached Weiler neonatal intensive care unit (NICU) hypoglycemia screening protocol). The investigators will compare neurodevelopmental outcomes of those who were and were not hypoglycemic in the newborn nursery based on electronic health record data.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 19, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2021
Actual (reported)May 6, 2021
Actual (reported)July 14, 2021
Actual (reported)July 19, 2024
Actual (reported)July 19, 2024
Actual (reported)Comparison of cognitive development using Bayley-4 scoring system
Compare cognitive development assessed with the Bayley-4 scoring system between the normoglycemic and hypoglycemic at-risk SGA/late preterm neonates
120 minutes
Comparison of motor development using Bayley-4 scoring system
Assess motor development between the normoglycemic and hypoglycemic at-risk neonates
120 minutes
Comparison of language development using Bayley-4 scoring system
120 minutes
Comparison of social-emotional behavior using Bayley-4 scoring system
120 minutes
Comparison of adaptive behavior using Bayley-4 scoring system
120 minutes
Preterm or small for gestational age neonates at risk for hypoglycemia who were found to be hypoglycemic during the screening for hypoglycemia
Preterm or small for gestational age neonates who were found to be normoglycemic during the screening for hypoglycemia
Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) will be administered by one of the 2 blinded examiners who are unaware of neonatal glycemia status. Bayley-4 examines Cognitive, Language, Motor, Social-Emotional and Adaptive Behavior domains of development and may require up to 120 minutes to complete.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This is a cross-sectional study evaluating neurodevelopmental outcome at 18 to 24 months of SGA/late preterm neonates who received risk-based screening for hypoglycemia and were found to be either normoglycemic or hypoglycemic during hospitalization. Eligible subjects will be identified via electronic health record search, and their hypoglycemia risk factors will be verified together with glycemia status. Parents of eligible subjects will be contacted via phone and invited for research participation; Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) will be administered by one of the 2 blinded examiners who are unaware of neonatal glycemia status. Bayley-4 examines Cognitive, Language, Motor, Social-Emotional and Adaptive Behavior domains of development .
Montefiore Medical Center, Weiler Hospital
The Bronx, New York, 10461, United States
Jillian Connors, MD
Montefiore Medical Center
126 participants (actual enrollment reported by the registry).
First Submitted
April 29, 2021
First Posted
May 6, 2021
Study Start
July 14, 2021
Actual (reported)Experience With a Pediatric Summer Intensive Therapy Program
Contact the study team to confirm eligibility.
Primary Completion
July 19, 2024
Actual (reported)Study Completion
July 19, 2024
Actual (reported)Last Updated
October 14, 2025
Record last verified: 2025-10
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Source: ClinicalTrials.gov.
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