Preterm Infant Growth

Nestlé

Status

Completed

Conditions

Infant

Development

Growth

Treatments

Other: infant formula

Other: control infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01162798

09.02.US.INF

Details and patient eligibility

About

The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.

Enrollment

150 patients

Sex

All

Ages

Under 1 month old

Volunteers

No Healthy Volunteers

Inclusion criteria

Born AGA
Exclusively formula-fed
28-34 weeks GA at birth
Intact GI tract, tolerating full oral feeds
Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

Exclusion criteria

Severe respiratory disease defined as needing mechanical ventilation at discharge
Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
Major congenital malformation, history of GI surgery, severe postnatal complications
Daily or routine diuretic use at time of discharge
Receiving more than 10% of daily kcals from food additives such as thickeners
Currently participating or having participated in another conflicting clinical trial.