Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

Completed

• Conditions: Preterm Birth; Premature Birth
• Interventions: Device: PEA POD Infant Body Composition System

• Registration Number: NCT02622373
• Lead Sponsor: Vishal Pandey, M.D.

Brief Summary

The purpose of this study is to gain information that may be useful in helping to figure out better or newer ways to provide nutrition to babies born premature.

Detailed Description

Babies born premature weigh significantly less at the time of hospital discharge when compared to babies born at the corresponding age. The researchers in this study believe that the lower body weight at discharge may be due to lower muscle mass. However, there is no such information available for that at this time. It is important to have this information as babies who weigh less than normal at hospital discharge may develop higher blood pressure and higher sugar levels when they are 10-15 years old.

By doing this study, researchers will be able to have information about the baby's muscle mass, which will help the researchers to provide better nutrition to babies who are born premature. Researchers will also be able to determine if there are any differences in the muscle/fat mass based on the type of feeding (breast milk alone, formula alone or a combination of breast milk and formula). This information may be beneficial in helping to promote the appropriate type of feeding for babies born premature.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-11-16
• Primary Completion: 2015-12
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Study Completion: 2016-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-18
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Newborns <32 weeks gestational age, singleton or multiple gestation
• 34-36 weeks gestational age newborns
• Term healthy infants from uncomplicated pregnancy

Exclusion Criteria

• Babies with life threatening illness unlikely to survive
• Congenital and chromosomal anomalies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Birth Between 34-36 Weeks Gestation	PEA POD Infant Body Composition System	Babies born at 34 weeks and 36 weeks of gestational age will have their body composition measured using PEA POD Infant Body Composition System as soon as they are off parenteral nutrition and receiving full enteral nutrition.
Birth Between 23-32 Weeks Gestation	PEA POD Infant Body Composition System	Babies born between 23-32 weeks of gestational age will have their body composition determined using PEA POD Infant Body Composition System at 34 weeks, 36 weeks and 40 weeks of corrected age.
Birth at Term	PEA POD Infant Body Composition System	Body composition will be measured using PEA POD Infant Body Composition System in this group will be obtained prior to discharge.

Primary Outcome Measures

Name	Time	Method
Change in the Fat mass percentage between 36 and 40 weeks in preterm infants	Change in the Fat mass percentage between 36 weeks and 40 weeks corrected age	Body composition as determined by the PEA POD air displacement plathesmography would determine the fat mass percentage and the serial measure of this parameter would determine the changes in the fat mass percentage indicating the quality of growth between 36 and 40 weeks post conceptional age. At 40 weeks corrected age, the fat mass percentage of the premature infants would be compared with ten healthy term infants born to healthy mothers with uncomplicated pregnancies.

Secondary Outcome Measures

Name	Time	Method
Comparison of the Fat mass percent between preterm infants at 40 weeks and those born at Term gestation.	40 weeks corrected age	The Fat mass percentage in preterm infants at the 40 weeks corrected age would be compared with healthy full term infants born following an uncomplicated pregnancy.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States