Neurodevelopment of Hypoglycemic Neonates
Neurodevelopmental Outcome of Normoglycemic Versus Hypoglycemic Neonates at Risk for Hypoglycemia
1 other identifier
observational
126
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2021
CompletedFirst Posted
Study publicly available on registry
May 6, 2021
CompletedStudy Start
First participant enrolled
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2024
CompletedOctober 14, 2025
October 1, 2025
3 years
April 29, 2021
October 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
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
Study Arms (2)
Hypoglycemic neonates
Preterm or small for gestational age neonates at risk for hypoglycemia who were found to be hypoglycemic during the screening for hypoglycemia
Normoglycemic neonates
Preterm or small for gestational age neonates who were found to be normoglycemic during the screening for hypoglycemia
Interventions
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.
Eligibility Criteria
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 .
You may qualify if:
- Born at 35 weeks or more of gestation
- Birth weight of 2000 g or more
- Indication for routine screening for hypoglycemia: late preterm infants (gestational age from 35 weeks 0 days to 36 weeks 6 days) and newborns who were SGA (birth weight below the 10th percentile on the 2013 Fenton curve).
You may not qualify if:
- Neonates with indication for hypoglycemia screening - screening not properly done or missing
- Unable to reach the subject for neurodevelopmental assessment
- Non-English speaking subjects
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center, Weiler Hospital
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jillian Connors, MD
Montefiore Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2021
First Posted
May 6, 2021
Study Start
July 14, 2021
Primary Completion
July 19, 2024
Study Completion
July 19, 2024
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share