Testing Four Feeding Approaches to Oral Feeding in Preterm Infants

Feeding Readiness in Preterm Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02024828

Acronym

PRO

Enrollment

109

Registered

2013-12-31

Start date

2006-07-31

Completion date

2012-04-30

Last updated

2013-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infant

Keywords

Infant feeding

Brief summary

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.

Detailed description

The study is completed.

Interventions

OTHEREarly/Slow

OTHEREarly/Fast

OTHERLate/Slow

OTHERLate/Fast

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 32 Weeks

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.

Design outcomes

Primary

Measure	Time frame	Description
Feeding Performance	One oral feeding a day for 14 days	Includes 3 components: Proportion consumed (volume taken/volume ordered), rate of consumption (volume consumed/minutes of feeding); proficiency (volume taken in first 5 minutes of feeding/volume ordered)

Secondary

Measure	Time frame	Description
Clinical outcomes	Participants will be followed for the duration of the hospital stay, an expected average from starting oral feedings of 3 weeks	Days to discharge from first oral feeding
Post-discharge feeding	2 weeks after discharge	Performance at feeding 2 weeks after hospital discharge using the Early Infant Feeding Scale, an observational tool of infant feeding behaviors

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026