Testing Four Feeding Approaches to Oral Feeding in Preterm Infants (PRO)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Preterm Infant

Treatments: Other: Early/Fast; Other: Late/Fast; Other: Late/Slow; Other: Early/Slow

Study type: Interventional

Funder types: Other

Identifiers

NCT02024828

R01NR005182

Details and patient eligibility

About

The purpose of this study was to test the effect of four randomly assigned approaches to oral feeding transition on feeding outcomes in preterm infants.

Full description

The study is completed.

Enrollment: 109 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. the infant's gestational age at birth was less than 32 weeks; 2) the infant was receiving enteral feedings every three hours; 3) the infant was able medically to feed orally by 32 weeks post-menstrual age (PMA); and 3) the parents gave consent for the infant's participation.

Exclusion criteria

• 1. they were unable to begin oral feeding at 32 weeks PMA due to gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects; 2) had surgical necrotizing enterocolitis; or 3) needed ventilator support, including nasal continuous positive airway pressure (CPAP), beyond 32 weeks PMA. Infants receiving oxygen by cannula were included.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 4 patient groups

Early/Slow

Experimental group

Description:

Infants were offered oral feedings beginning at 32 weeks PMA. They were offered 2 oral feedings per day for 3 days (Days 1-3). The number of oral feedings offered per day increased by 1 feeding every other day until day 14 when they were offered 8 oral feedings each day (Days 4-5, 3 oral feeds offered; Days 6-7, 4 oral feeds offered; Days 8-9, 5 oral feeds offered; Days 10-11, 6 oral feeds offered; Days 12-13, 7 oral feeds offered; Day14, 8 oral feeds offered). Any feedings not offered orally were provided by gavage.

Treatment:

Other: Early/Slow

Early/Fast

Experimental group

Description:

Infants were first offered oral feedings beginning at 32 weeks PMA. They were offered 8 oral feedings every day, at each of 8 scheduled daily feedings.

Treatment:

Other: Early/Fast

Late/Slow

Experimental group

Description:

Infants were offered oral feedings beginning at 34 weeks PMA. They were offered 2 oral feedings per day for 3 days (Days 1-3). The number of oral feedings offered per day increased by 1 feeding every other day until day 14 when they were offered 8 oral feedings each day (Days 4-5, 3 oral feeds offered; Days 6-7, 4 oral feeds offered; Days 8-9, 5 oral feeds offered; Days 10-11, 6 oral feeds offered; Days 12-13, 7 oral feeds offered; Day14, 8 oral feeds offered). Any feedings not offered orally were provided by gavage.

Treatment:

Other: Late/Slow

Late/Fast

Experimental group

Description:

Infants were offered oral feedings beginning at 34 weeks PMA. They were offered 8 oral feedings every day, at each of 8 scheduled daily feedings.

Treatment:

Other: Late/Fast