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Impact of Currently Recommended Postnatal Nutrition on Neonatal Body Composition

V

Vishal Pandey, M.D.

Status

Completed

Conditions

Preterm Birth
Premature Birth

Treatments

Device: PEA POD Infant Body Composition System

Study type

Observational

Funder types

Other

Identifiers

NCT02622373
STUDY00002323

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

23 to 42 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

40 participants in 3 patient groups

Birth Between 23-32 Weeks Gestation
Description:
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.
Treatment:
Device: PEA POD Infant Body Composition System
Birth Between 34-36 Weeks Gestation
Description:
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.
Treatment:
Device: PEA POD Infant Body Composition System
Birth at Term
Description:
Body composition will be measured using PEA POD Infant Body Composition System in this group will be obtained prior to discharge.
Treatment:
Device: PEA POD Infant Body Composition System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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