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Completed

NCT Number: NCT01162798

Preterm Infant Growth

The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.

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Key information

Conditions

Growth Development Female Urogenital Diseases and Pregnancy Complications Infant Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital & Research Center, Oakland, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born AGA
  • Exclusively formula-fed
  • 28-34 weeks GA at birth
  • Intact GI tract, tolerating full oral feeds
  • Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

Exclusion criteria

  • Severe respiratory disease defined as needing mechanical ventilation at discharge
  • Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
  • Major congenital malformation, history of GI surgery, severe postnatal complications
  • Daily or routine diuretic use at time of discharge
  • Receiving more than 10% of daily kcals from food additives such as thickeners
  • Currently participating or having participated in another conflicting clinical trial.

Treatment and study plan

Infant Formula

Other

test infant formula fed to infants until 6 months corrected gestational age

Other names: test infant formula

Control infant formula

Other

commercially available infant formula

Other names: commercially available infant formula fed to infants until 6 months corrected gestational age

Primary outcomes

  1. Growth

    Time frame: 4 months

    weight gain assessed monthly

Secondary outcomes

  1. growth, tolerance, morbidity

    Time frame: 6 months

    gains in length and head circumference assessed monthly, tolerance and morbidity throughout study

  2. Total body bone mineral content and density and body composition, protein status, and metabolic markers

    Time frame: corrected term and 4 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Growth of Preterm Infants Consuming Formula

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 15, 2010
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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