NCT04975282

Brief Summary

Breastfeeding is the ideal feeding method and that in the absence of breastfeeding the bottle and cup feeding are common alternatives. There is a lack of evidence regarding superiority of either of these methods. This study aimed to evaluate bottle feeding and cup feeding in preterm infants on the outcomes of full breastfeeding and discharge time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

February 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

July 12, 2021

Last Update Submit

July 21, 2021

Conditions

Keywords

Preterm infantsBottle feedingCup feedingFeeding methodsBreastfeeding

Outcome Measures

Primary Outcomes (2)

  • Transition to Full Breastfeeding

    Preterm infants fed with bottle (n=78) and cup (n=80) were compared in terms of transition to full breastfeeding. The transition period from oral feeding to full breastfeeding is different for every preterm infants. There is no specific time frame in the study. For this outcome, infants were evaluated for time from oral feeding to full breastfeeding.

    From transition to breastfeeding, up to 1 week.

  • Discharge Time

    Preterm infants fed with bottle (n=78) and cup (n=80) were compared in terms of discharge times. There is no specific time frame in the study. For this outcome, infants were evaluated for lenght of stay hospital.

    From admission to discharge, up to 4 weeks

Study Arms (2)

Bottle Feeding

The bottle feeding method was being used in the NICU (1 January -31 December 2018).

Device: Bottle feeding

Cup Feeding

The cup feeding method was being used in the NICU (1 January -31 December 2019).

Device: Cup feeding

Interventions

Bottle was used as an alternative oral feeding method for preterm infants.

Bottle Feeding

Cup was used as an alternative oral feeding method for preterm infants.

Cup Feeding

Eligibility Criteria

Age30 Weeks - 34 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preterm infants between 30-34 weeks and healthy

You may qualify if:

  • Preterm infants (30-34 weeks);
  • Considered medically stable
  • With no facial deformity,
  • Absent of neurological or congenital anomalies,
  • Did not require sedation or vasoactive drugs
  • Mother is providing breast milk \& plans to breastfeed.

You may not qualify if:

  • Presence of gastrointestinal conditions that complicate feeding such as NEC,
  • Absence of mother,
  • Absence of breast milk, and
  • Preterm infants fed only formula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature BirthBottle FeedingFeeding BehaviorBreast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehaviorBehavior, Animal

Study Officials

  • Zühal Çamur, RN, PhD

    Pamukkale University

    PRINCIPAL INVESTIGATOR
  • Bengü Çetinkaya, RN, PhD

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator RN, PhD

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 23, 2021

Study Start

February 20, 2020

Primary Completion

April 30, 2020

Study Completion

May 20, 2020

Last Updated

July 23, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations