Early Childhood Obesity Programming by Intrauterine Growth Restriction
Recruiting
Observational Study
Childhood ObesityEpigenetics
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
1 Hour – 24 Months
Sex
Any
Study type
Observational
Participants needed
400 (estimated)
Sponsor
Montefiore Medical Center · Other
Who this trial is looking for
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The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life.
Trial Locations
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Eligibility Criteria
Mother-infant pairs will be recruited for this study.
Inclusion Criteria:
* 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 Weil…
Mother-infant pairs will be recruited for this study.
Inclusion Criteria:
* 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 Criteria:
* 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
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