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

Premature Birth of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01759134
• Other study ID #: chammermanpdc
• Status: Terminated
• Phase: Phase 4
• First received: January 2, 2012
• Last updated: October 24, 2013
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2012
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Weeks to 34 Weeks

Eligibility

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)

Study Design

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth
• Premature Birth of Newborn

Intervention

Other:
• Post discharge formula
Babies will be given either materna sensitive or similac neosure

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	growth	weight (kg), length (cm), head circumference (cm).	3 months post discharge	No