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Completed

NCT Number: NCT01140243

Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.

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Key information

Conditions

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

Age range

2 week–6 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit, Barzilai Medical Center, Ashkelon, Israel

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
  • whose mothers are unable to breast feed or have chosen not to breast feed,
  • Whose parents have signed the informed consent form.
  • Only the first among twins will be recorded for the study.

Exclusion criteria

  • Chromosomal abnormalities or congenital malformation.
  • Metabolic abnormalities.
  • Central nervous system abnormalities.
  • Severe developmental disorders.
  • GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
  • Milk allergy or intolerance.
  • Growth failure.
  • Chronic disease

Treatment and study plan

LCPUFA

Dietary Supplement

premature infant formula supplemented with LCPUFA

Primary outcomes

  1. anthropometric

    Time frame: 12 weeks

    anthropometric measure will be taken at the time of recruitment and on the following 4, 8 and 12 weeks

Sponsors and collaborators

Lead sponsor

Materna Laboratories

Industry

Registry information

Official study title

Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 9, 2010
Registry last updated
May 29, 2013

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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