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NCT04875624 · ClinicalTrials.gov registry record
Neurodevelopment of Hypoglycemic Neonates
A clinical trial, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- 126
- Enrollment target
NCT04875624: Completed study, sponsored by Montefiore Medical Center.
NCT04875624 is a clinical trial that has completed, run by Montefiore Medical Center. The registered enrollment target is 126 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04875624 has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- 126 participants
- Enrollment target
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.
Primary Outcome
Compare cognitive development assessed with the Bayley-4 scoring system between the normoglycemic and hypoglycemic at-risk SGA/late preterm neonates
Interventions
- DIAGNOSTIC_TEST Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2024-07-19 |
What the finished NCT04875624 record still lists
NCT04875624 is an observational study that tracks outcomes without assigning an intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) is the first listed.
NCT04875624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04875624 about?
NCT04875624 is a clinical study titled "Neurodevelopment of Hypoglycemic Neonates". 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 ...
What is the current status of trial NCT04875624?
This trial is currently completed. The enrollment target is 126 participants. The study started on 2021-07-14. Estimated completion is 2024-07-19.
What interventions are being tested in trial NCT04875624?
The interventions under investigation include: Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04875624?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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