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OpenTrials
Completed

NCT Number: NCT01987154

Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

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Key information

Conditions

Feeding Intolerance

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera "Ospedale Policlinico Consorziale" di Bari

Bari, Apulia, 70124, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Premature infant 28 to 33 weeks gestational age, inclusive, at birth
  • Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
  • Birth weight is greater than or equal to 700g to 1750g
  • Appropriate birth weight for gestational age
  • Singleton or twin birth
  • Signed Informed consent

Exclusion criteria

  • Infant's mother plans to exclusively breast feed
  • 5 minute APGAR score is less than or equal to 4
  • Major surgery that required general anesthesia prior to randomization
  • Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
  • Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
  • Infant is currently participating in another clinical study

Treatment and study plan

Marketed cow milk-based premature infant formula

Other

Marketed extensively hydrolyzed casein infant formula

Other

Primary outcomes

  1. Enteral intake (ml/kg/day)

    Time frame: Daily for 14 days

Secondary outcomes

  1. Body Weight (g)

    Time frame: Daily for 14 days

  2. Feeding Tolerance

    Time frame: Daily for 14 days

    Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day)

  3. Respiratory status

    Time frame: Daily for 14 days

    Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation

  4. Gut Inflammation

    Time frame: Once at Study Day 14

    Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound

  5. Confirmed or suspected sepsis or necrotizing enterocolitis

    Time frame: Daily for 14 days

  6. Date of hospital discharge

    Time frame: Once at hospital discharge

  7. Growth

    Time frame: Study Days 1, 7, and 14

    length (cm) and head circumference (cm)

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2013
Registry last updated
May 17, 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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