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

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Abbott

Status and phase

Completed
Phase 3
Phase 2

Conditions

Pre-term Infants

Treatments

Other: study pre-term formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01766011
AL01

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

Under 21 days old

Volunteers

No Healthy Volunteers

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

Trial design

28 participants in 1 patient group

study pre-term formula
Experimental group
Description:
Pre-term formula with a modified stabilizer system in 2 oz. ready to feed plastic bottles
Treatment:
Other: study pre-term formula

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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