NCT00756587

Brief Summary

The purpose of the current study is to investigate the effect of using cup feeding for preterm infants during NICU stay on breastfeeding outcomes after discharge. The following hypotheses are being tested:

  1. 1.Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle
  2. 2.Infants fed by cup during NICU stay will have higher breastfeeding behaviour score on the Preterm Infant Breastfeeding Behavior Scale than infants fed by bottle

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2003

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

Study Start

First participant enrolled

December 1, 2003

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
Last Updated

October 31, 2008

Status Verified

September 1, 2008

Enrollment Period

8 months

First QC Date

September 19, 2008

Last Update Submit

October 30, 2008

Conditions

Breastfeeding

Keywords

Cup Feedinglate Preterm

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Proportion

    one week

Study Arms (2)

I

ACTIVE COMPARATOR

Group one received feeding by bottle as the standard method of feeding in the NICU

Device: Bottle Feeding

II

EXPERIMENTAL

Group 2 received all feeding by cup

Device: Cup Feeding

Interventions

Cup FeedingDEVICE

using a cup feeding technique for feeding the preterm infants during NICU stay

Also known as: Cup-feeding Group
II
Bottle FeedingDEVICE

receiving all feeding by bottle

Also known as: bottle feeding group
I

Eligibility Criteria

Age34 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Singleton birth
  • to 37 weeks of gestation at birth
  • Maternal intention to breastfeed
  • Fed only by tube feeding

You may not qualify if:

  • Infants who had any condition interfering with oral feeding
  • Infants with craniofacial anomalies
  • Infants with intracranial hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peiatric University NICU

Cairo, Cairo Governorate, 00000, Egypt

Location

Related Publications (1)

  • Abouelfettoh AM, Dowling DA, Dabash SA, Elguindy SR, Seoud IA. Cup versus bottle feeding for hospitalized late preterm infants in Egypt: a quasi-experimental study. Int Breastfeed J. 2008 Nov 21;3:27. doi: 10.1186/1746-4358-3-27.

    PMID: 19025602DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Amel M Abouelfettoh, PhD, RN

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

December 1, 2003

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

October 31, 2008

Record last verified: 2008-09

Locations

EG(1)