Cup Versus Bottle Feeding for Late Preterm Infants

Breastfeeding Clinical Trial

Official title:

Cup Versus Bottle Feeding for Hospitalized Late Preterm Infants in Egypt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756587
• Other study ID #: 2004
• Status: Completed
• Phase: N/A
• First received: September 19, 2008
• Last updated: October 30, 2008
• Start date: December 2003
• Est. completion date: August 2004

Study information

• Verified date: September 2008
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. Infants Fed by cup during NICU stay will have higher breastfeeding proportions than infants fed by bottle

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 34 Weeks to 37 Weeks

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Device:
• Cup Feeding
using a cup feeding technique for feeding the preterm infants during NICU stay
• Bottle Feeding
receiving all feeding by bottle

Locations

Country	Name	City	State
Egypt	Peiatric University NICU	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding Proportion		one week	No