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

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