NCT02027688

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

December 31, 2013

Last Update Submit

December 1, 2015

Conditions

Feeding BehaviorFeeding PatternsInfant, Premature, Diseases

Keywords

Oral feedingPrematureInfantsNeonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Time to full oral feeds

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

    38 weeks gestation on average

Secondary Outcomes (4)

  • Time to discharge

    40 weeks gestation on average

  • Medical Complications

    38 weeks gestation on average

  • Growth

    40 weeks gestation on average

  • Feeding skills

    40 weeks gestation on average

Study Arms (2)

Every 6 hour Feeding Schedule

ACTIVE COMPARATOR

Infants in this arm will be offered oral feedings every 6 hours if they are safe and ready to feed by mouth.

Other: q6 hour oral feeding schedule

Every 3 Hour Oral Feeding

ACTIVE COMPARATOR

Infants in this arm will be offered oral feedings every 3 hours if they are safe and ready to feed by mouth.

Other: q3 hour oral feeding schedule

Interventions

q6 hour oral feeding scheduleOTHER

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

Every 6 hour Feeding Schedule
q3 hour oral feeding scheduleOTHER

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

Every 3 Hour Oral Feeding

Eligibility Criteria

AgeUp to 120 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Infant, Premature, DiseasesFeeding BehaviorPremature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior, AnimalBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sara B DeMauro, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSCE

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 6, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

US(2)