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Does low blood sugar at birth affect toddler development?

NCT ID NCT04875624

Knowledge-focused Sponsor: Montefiore Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study followed 126 babies born at 35 weeks or later who were at risk for low blood sugar (hypoglycemia). Researchers compared those who had low blood sugar in their first day of life with those who did not, testing their thinking, movement, and language skills at 18 to 24 months old. The goal was to see if brief low blood sugar affects long-term development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could clarify whether brief neonatal hypoglycemia affects long-term brain development, guiding future monitoring and care.
What could go wrong
This is an observational study with a small sample (126 infants) and no intervention, so it cannot prove cause and effect. Results may not apply to all at-risk newborns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

126 people

The number who actually took part.

Started

Jul 2021

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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 .

Ages

18 to 24 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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). Exclusion Criteria: * Neonates with indication for hypoglycemia screening - screening not properly done or missing * Unable to reach the subject for neurodevelopmental assessment * Non-English speaking subjects

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Conditions

The condition(s) this trial relates to.

neurodevelopmental disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal hypoglycemia Neurodevelopmental disorders

Contacts and locations

Locations

  • Montefiore Medical Center, Weiler Hospital

    The Bronx, New York, 10461, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.