RecruitingNCT03402139
Early Childhood Obesity Programming by Intrauterine Growth Restriction
Molecular Basis of Early Childhood Obesity Programming by Intrauterine Growth Restriction
Sponsor
Montefiore Medical Center
Enrollment
400 participants
Start Date
Sep 1, 2018
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 1 HourMax Age: 24 Months
Inclusion Criteria5
- Mother-infant pairs will be recruited for this study.
- 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 Criteria11
- 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03402139