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Completed

NCT Number: NCT02027688

Feeding Progression in Preterm Infants

Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.

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Key information

Conditions

Infant, Premature, Diseases Behavior Behavior, Animal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Feeding Behavior Feeding Patterns Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 120 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

Preterm infants are at high risk for feeding issues. Feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. The transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. Currently, there is limited evidence to guide this transition. There are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. However, there is currently no evidence to guide providers in their choice of oral feeding schedule.

The primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. The secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. Each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. Data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. The study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. This study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age between 23 0/7-33 0/7 weeks
  • Eligible for oral (PO) feeding as determined by the attending Neonatologist

Exclusion criteria

  • Infants with major congenital malformations
  • Infants with chromosomal defects
  • Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
  • Grade 3 or 4 Intraventricular Hemorrhage

Treatment and study plan

q6 hour oral feeding schedule

Other

The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.

q3 hour oral feeding schedule

Other

The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.

Primary outcomes

  1. Time to full oral feeds

    Time frame: 38 weeks gestation on average

    Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.

Secondary outcomes

  1. Time to discharge

    Time frame: 40 weeks gestation on average

    Assess the relationship between feeding schedule and overall length of hospitalization.

  2. Medical Complications

    Time frame: 38 weeks gestation on average

    Explore the relationship between feeding schedule and medical complications including apnea of prematurity, bronchopulmonary dysplasia, episodes of suspected sepsis, feeding intolerance and physiologic instability during the time of oral feeds.

  3. Growth

    Time frame: 40 weeks gestation on average

    Assess the growth during the period of time from initiation of oral feeds to reaching complete oral feeds.

  4. Feeding skills

    Time frame: 40 weeks gestation on average

    Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2014
Registry last updated
Dec 2, 2015

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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