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Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas

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ClinicalTrials.gov Identifier: NCT01759134
Recruitment Status : Terminated
First Posted : January 2, 2013
Last Update Posted : October 25, 2013
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Brief Summary:
The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Condition or disease Intervention/treatment Phase
Premature Birth of Newborn Other: Post discharge formula Phase 4

Detailed Description:
Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Post Discharge Formula
Babies will be given formula for first three months post discharge
Other: Post discharge formula
Babies will be given either materna sensitive or similac neosure

Primary Outcome Measures :
  1. growth [ Time Frame: 3 months post discharge ]
    weight (kg), length (cm), head circumference (cm).

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Ages Eligible for Study:   30 Weeks to 34 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
  2. Gestational week 30-34.

Exclusion Criteria:

  1. Congenital major malformation (e.g. congenital heart disease).
  2. Chromosomal abnormality (e.g. Down's syndrome)
  3. Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
  4. Milk allergy
  5. Chronic disease (e.g. oxygen treatment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759134

Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Principal Investigator: Alona Bin-Nun, MD Shaare Zedek Medical Center
Principal Investigator: Cathy Hammerman, MD Shaare Zedek Medical Center

Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01759134     History of Changes
Other Study ID Numbers: chammermanpdc
First Posted: January 2, 2013    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: December 2012

Keywords provided by Shaare Zedek Medical Center:
Premature neonate

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications