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Completed

NCT Number: NCT02024828

Testing Four Feeding Approaches to Oral Feeding in Preterm Infants

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.

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CCHMC

Cincinnati, Ohio, 45229, United States

About this study

The study is completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early/Slow

Other

Early/Fast

Other

Late/Slow

Other

Late/Fast

Other

Primary outcomes

  1. Feeding Performance

    Time frame: 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 outcomes

  1. Clinical outcomes

    Time frame: 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

  2. Post-discharge feeding

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Virginia Commonwealth University

Registry information

Official study title

Feeding Readiness in Preterm Infants

Acronym: PRO

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Dec 31, 2013
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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