Observational Study on Childhood Obesity and Intrauterine Growth Restriction

This observational study is looking into how being born with intrauterine growth restriction (IUGR), meaning slower growth in the womb, might lead to childhood obesity. Researchers want to understand the molecular reasons behind this link, specifically by studying certain immune cells (CD3+ T-cells) in babies. They will look at how these cells change at birth and at 24 months of age, and how these changes relate to a baby's growth. You might be able to join if you are a mother delivering at Montefiore Medical Center (Weiler Division) and your baby is a healthy singleton, either with IUGR or of appropriate size for their gestational age. The study aims to understand what causes childhood obesity in babies born with IUGR.

Study design
This is an observational study planning to enroll 400 mother-infant pairs. It is not testing a specific intervention or drug.
What's involved
The study involves collecting blood samples from your baby at birth and at 24 months of age. Your baby's growth will also be measured until 24 months of age.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until their baby is 24 months old.

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NCT03402139

Early Childhood Obesity Programming by Intrauterine Growth Restriction

Recruiting
Not specifiedAges 1–24Observational
Montefiore Medical Center
~400 participants
Updated 2025-09-15 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Growth velocity
Measured over Until 24 months of age
+2 more outcomes measured
Childhood Obesity
Epigenetics
1 sites across 1 states
New York1
  • Sandra Reznik, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center/Albert Einstein College of Medicine

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Eligibility criteria

Inclusion

Healthy singleton term intrauterine growth restricted (IUGR) and appropriate for gestational age (AGA) infants whose mothers are followed by the Obstetric Department of Montefiore Medical Center and who deliver at the Weiler Division of Montefiore Medical Center. Infants will be classified as IUGR if birth weight is \<10th percentile for gestational age and gender based on World Health Organization (WHO) growth curves. Infants will be classified as AGA if birth weight percentile is \>10th and \<90th percentile
Reproductive age women, healthy enough to achieve pregnancy
Deliver a single healthy live term infant at ≥37 weeks' gestational age (GA)
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion

Multiple gestation
Maternal depression
Maternal renal disease
History of maternal smoking in the 2nd and 3rd trimester of pregnancy
Maternal gestational diabetes / Type 2 Diabetes (T2D)
Preterm birth (less than 37 weeks' gestation)
Known chromosomal or congenital anomaly
Infants in extremis
Low Apgar scores (Apgar score \<7 at 5 minutes of age)
Known congenital bacterial or non-bacterial infections
Known inborn errors of metabolism
  • Growth velocityUntil 24 months of age

    Change in growth velocity based on DNA methylation marks and functional profiles of CD3+ T-cells

  • DNA methylation of CD3+ T-cellsAt birth and 24 months of age

    Change in DNA methylation of CD3+ T-cells in the first 24 months of life in IUGR infants

  • T-cell functionAt birth, 12 and 24 months of age

    Change in T-cell function in the first 24 months of life in IUGR infants