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Completed

NCT Number: NCT01771588

Human Milk Fortifier - Growth Evaluation

It it is hypothesized that the growth of preterm infants receiving a new human milk fortifier will be equal or superior to the growth of preterm infants receiving a currently marketed human milk fortifier with a lower protein content.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

Up to 1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR de la Citadelle, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Birth weight ≤1500 g AND/OR gestational age ≤32 weeks (determined by maternal dates, fetal ultrasound, Dubowitz/Ballard examination or a combination thereof)
  • Male or female
  • Tolerating an enteral intake of human milk, donor milk or a combination at ≥100 mL/kg/d for ≥ 24 h
  • Subject is anticipated to receive human milk, donor milk or a combination for ≥ 3 consecutive weeks after having achieved full fortification with volume intake contained between 150 and 180 mL/kg/d.
  • Written informed consent has been obtained from the legal representative(s).

Exclusion criteria

  • Infants with current systemic disease
  • Infants with a history of systemic disease
  • Any congenital anomalies of the GI tract that significantly interfere with nutrition and growth or previous GI surgery.
  • Small size for gestational age (SGA) - body weight ≦ 5th percentile for that gestational age.
  • Infants diagnosed with any inherent metabolic disease.
  • Infants diagnosed with any chromosomic disease.
  • Receiving any commercial formula supplementation to breast milk.
  • Receiving steroids at the time of enrollment.
  • Participation in another nutritional clinical trial that may affect outcomes of this study.

Treatment and study plan

Human Milk Fortifier

Dietary Supplement

Primary outcomes

  1. Weight gain (g/d) between full strength fortification with full volume intake (day 1) through 21 days of study after that day.

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Evaluation of Growth of Pre-Term Infants Fed a Human Milk Fortifier

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 18, 2013
Registry last updated
May 5, 2016

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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