Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation \[32-35 weeks post-menstrual age (PMA)\] premature infants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography and Multiple-frequency Bio-impedance Analysis

NCT00890344

Neonates

COMPLETED

Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants

NCT01341236

Infant, Very Low Birth Weight Infant Malnutrition Feeding Disorder of Infancy or Early Childhood +2 more

COMPLETED PHASE4

Growth and Body Composition in Preterm Infants

NCT00875251

Body Composition

UNKNOWN

Post-Discharge Growth of Infants Who Received Donor Human Milk Products in the Neonatal Intensive Care Unit (NICU)

NCT01483079

Prematurity

ACTIVE_NOT_RECRUITING

Body Composition Reference Data for Preterm Infants

NCT02855814

Preterm Birth

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth.
2. To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.
3. To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements.
4. Compare growth, body composition and bone strength between infants born preterm to infants born full term.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Full Term Infants

Infants born between 37 4/7 weeks and 42 3/7 weeks gestation.

No interventions assigned to this group

Preterm Infants

Infants born between 32 4/7 weeks and 35 3/7 weeks gestation.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth
* Birth weight between the 5th and 95th percentile corrected for gestational age

Exclusion Criteria

* Chromosomal abnormalities
* Major congenital anomalies
* Major surgery
* Severe CNS injury
* Inborn errors of metabolism
* Assisted ventilation
* Inability to start enteral feeds by 96 hours of age

Minimum Eligible Age

31 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes