NCT02916914

Brief Summary

Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are not proposed with regards to results of randomized controlled trials. Investigators aimed to investigate the impact of 2-hourly feeding on time of transition from orogastric to oral feeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

September 30, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

September 8, 2016

Last Update Submit

August 13, 2017

Conditions

BottlefeedingInfant, Premature, Diseases

Keywords

pretermfeedingoral transition

Outcome Measures

Primary Outcomes (1)

  • time of transition from orogastric to oral feeding

    From date of birth to date of transition from orogastric to oral feeding or date of death, which ever came first, will be assessed up to 44th post menstrual age (days of life)

Secondary Outcomes (3)

  • feeding intolerance after randomization; intolerance events per week until discharge

    From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age

  • duration of hospitalization

    From date of birth to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (days of life)

  • weight gain per week until discharge

    From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (grams/kg/week)

Study Arms (2)

Q2 feeding

OTHER

feeding intervals: 2 hours

Other: Q2 feeding

Q3feeding

NO INTERVENTION

feeding intervals: 3 hours

Interventions

Q2 feedingOTHER

Infants are going to be fed every 2 hours

Q2 feeding

Eligibility Criteria

Age7 Days - 90 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • birth weight \<= 1500 gr gr
  • gestational age \<= 32 weeks
  • postnatal age at randomization: between 7 - 90 days

You may not qualify if:

  • congenital anomaly
  • multi organ failure
  • sepsis
  • surgical pathology
  • inherited metabolic diseases
  • exclusively formula feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EtlikWHTH

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (4)

  • Bergman NJ. Neonatal stomach volume and physiology suggest feeding at 1-h intervals. Acta Paediatr. 2013 Aug;102(8):773-7. doi: 10.1111/apa.12291. Epub 2013 Jun 3.

    PMID: 23662739BACKGROUND

  • Dhingra A, Agrawal SK, Kumar P, Narang A. A randomised controlled trial of two feeding schedules in neonates weighing <or=1750 g. J Matern Fetal Neonatal Med. 2009 Mar;22(3):198-203. doi: 10.1080/14767050802385749.

    PMID: 19330703BACKGROUND

  • Rudiger M, Herrmann S, Schmalisch G, Wauer RR, Hammer H, Tschirch E. Comparison of 2-h versus 3-h enteral feeding in extremely low birth weight infants, commencing after birth. Acta Paediatr. 2008 Jun;97(6):764-9. doi: 10.1111/j.1651-2227.2008.00774.x. Epub 2008 Apr 16.

    PMID: 18422805BACKGROUND

  • DeMauro SB, Abbasi S, Lorch S. The impact of feeding interval on feeding outcomes in very low birth-weight infants. J Perinatol. 2011 Jul;31(7):481-6. doi: 10.1038/jp.2010.153. Epub 2011 Jan 20.

    PMID: 21252961BACKGROUND

MeSH Terms

Conditions

Bottle FeedingInfant, Premature, DiseasesPremature Birth

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Sezin Unal, MD

    Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
UNKNOWN
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 28, 2016

Study Start

September 30, 2016

Primary Completion

May 31, 2017

Study Completion

August 1, 2017

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)