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Neurodevelopment of Hypoglycemic Neonates

NCT04875624 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2025-10-14

No results posted yet for this study

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.

Conditions

  • Neonatal Hypoglycemia
  • Neurodevelopmental Disorders

Interventions

DIAGNOSTIC_TEST

Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)

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.

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Jillian Connors, MD · Montefiore Medical Center

Eligibility

Min Age
18 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2024-07-19
Completion
2024-07-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875624 on ClinicalTrials.gov