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Cup Versus Bottle Feeding for Late Preterm Infants

Primary Purpose

Breastfeeding

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cup Feeding
Bottle Feeding
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding focused on measuring Cup Feeding, late Preterm

Eligibility Criteria

34 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Peiatric University NICU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

I

II

Arm Description

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

Group 2 received all feeding by cup

Outcomes

Primary Outcome Measures

Breastfeeding Proportion

Secondary Outcome Measures

Full Information

First Posted
September 19, 2008
Last Updated
October 30, 2008
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT00756587
Brief Title
Cup Versus Bottle Feeding for Late Preterm Infants
Official Title
Cup Versus Bottle Feeding for Hospitalized Late Preterm Infants in Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle 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
Detailed Description
The provision of breast milk is essential for preterm infants as it provides unique health benefits that are unmatched by other types of feeding [1-3]. However, breastfeeding presents unique challenges for preterm infants that include establishing and maintaining the mothers' milk supply and transitioning the infant from gavage feeding to breastfeeding [4]. One of the issues that presents during the transition to breastfeeding is that mothers of preterm infants are rarely available for all oral feedings during hospitalization; this makes it necessary for infants to receive oral feedings by other method, usually bottle feeding. However, exposure of newborn infants to artificial nipples has been strongly associated with breastfeeding problems [5-9]. Frequently these problems have been explained by phenomena called nipple confusion. Nipple confusion occurs when infants are exposed to two different feeding methods, bottle and breast, resulting in the infant refusing to breastfeed. Consequently, it has been recommended that bottle feeding be avoided and that cup feeding be used for the supplementation of term as well as preterm infants. Cup feeding is known as an alternative method of feeding breast milk to an infant using a small cup without a lip. Cup feeding is also recommended by the Baby Friendly Hospital Initiative.The use of cup was originally based on the goal of avoiding propping of bottles and also to increase bodily contact with the mother during feeding. Although cup feeding receives little mention in medical literature, and may seem to be a new technique for some, it has been used in several developing as well as developed countries. Lang, who observed cup feeding in South Nepal, implemented cup feeding in England and the practice expanded to other developed countries. Consequently cup feeding was established as a method for feeding infants who could not be breastfed from birth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding
Keywords
Cup Feeding, late Preterm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Group one received feeding by bottle as the standard method of feeding in the NICU
Arm Title
II
Arm Type
Experimental
Arm Description
Group 2 received all feeding by cup
Intervention Type
Device
Intervention Name(s)
Cup Feeding
Other Intervention Name(s)
Cup-feeding Group
Intervention Description
using a cup feeding technique for feeding the preterm infants during NICU stay
Intervention Type
Device
Intervention Name(s)
Bottle Feeding
Other Intervention Name(s)
bottle feeding group
Intervention Description
receiving all feeding by bottle
Primary Outcome Measure Information:
Title
Breastfeeding Proportion
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Singleton birth 34 to 37 weeks of gestation at birth Maternal intention to breastfeed Fed only by tube feeding Exclusion Criteria: Infants who had any condition interfering with oral feeding Infants with craniofacial anomalies Infants with intracranial hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amel M Abouelfettoh, PhD, RN
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peiatric University NICU
City
Cairo
ZIP/Postal Code
00000
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
19025602
Citation
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.
Results Reference
derived

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Cup Versus Bottle Feeding for Late Preterm Infants

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