Skip to main content
OpenTrials
Completed

NCT Number: NCT01766011

Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital

The purpose of this study is to assess overall growth of preterm infants fed a reformulated preterm infant formula during hospitalization. All study products meet levels of nutrients for the infant population as specified in the Infant Formula Act and all subsequent amendments.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

Up to 21 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of South Alabama - Children's and Women's Hospital, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects eligible for study participation will satisfy the following criteria:
  • Birth weight between 1000g -1800g
  • Less than or equal to 34 weeks and 0 days gestational age at birth
  • Appropriate for gestational age (AGA)
  • Singleton or twin births
  • Infant is 21 days of age or less

Exclusion criteria

  • Infants with the following conditions prior to and/or at the time of study product initiation are not eligible for entry into the study:
  • Expected to be transferred to another facility within 14 days
  • Serious congenital abnormalities that may affect growth and development
  • Intubated for ventilation at the time of study product initiation
  • Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH)
  • Maternal incapacity, maternal drug or alcohol abuse during pregnancy or current abuse, or maternal treatment consistent with human immunodeficiency virus therapy
  • Infant has a history of major surgery
  • Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia
  • Confirmed necrotizing enterocolitis or confirmed sepsis
  • Current use or planned use of probiotics
  • Participation in another study that has not been approved

Treatment and study plan

study pre-term formula

Other

24 kcal/fl oz pre-term formula for in-hospital use

Other names: Similac Special Care

Primary outcomes

  1. Weight gain per day

    Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

    weight gain per day (g/kg/d)

Secondary outcomes

  1. Length

    Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

    Growth, change in length

  2. Daily Stool Questionnaire

    Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

    Gastro-intestinal Tolerance; Presence of bloody, watery, hard or black stools will be captured.

  3. Serum Calcium

    Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)

    Blood biochemistries

  4. Head circumference

    Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

    Growth, change in head circumference

  5. Daily Feeding Questionnaire

    Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

    Gastro-Intestinal Tolerance; Cause for withholding feedings will be captured.

  6. Any periods of nil per os (NPO)

    Time frame: Study Day (SDAY) 1 to SDAY 29, or hospital discharge, whichever comes first

    Gastro-Intestinal Tolerance

  7. Phosphorus

    Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)

    Blood biochemistries

  8. Alkaline Phosphatase

    Time frame: SDAY 1, 15, and 29 or hospital discharge (whichever comes first)

    Blood biochemistries

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Mar 3, 2015

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.

Published trials that share one or more normalized conditions with this study.