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

Shaare Zedek Medical Center

Status and phase: Terminated; Phase 4

Conditions: Premature Birth of Newborn

Treatments: Other: Post discharge formula

Study type: Interventional

Funder types: Other

Identifiers

NCT01759134

chammermanpdc

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 34 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Post Discharge Formula

Experimental group

Description:

Babies will be given formula for first three months post discharge

Treatment:

Other: Post discharge formula