Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding

NCT00703950 | Terminated Phase 4

• 1 other identifier: CAAE-0288.0.008.000-05
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns in preterm infants. It will be a randomized blind study. One group will be randomized to use bottle to feed and another one to use a cup to feed. As secondary endpoints, weight gain, days of life to begin full oral feeding, length of hospital stay and breast feeding rates will be observed.

Conditions

Infant, Very Low Birth Weight

Keywords

Sucking patterns; preterm infants; breastfeeding

Outcome Measures

Primary Outcomes (1)

• Temporal parameters of sucking

  at discharge

Secondary Outcomes (1)

• days of life at full oral feeding; breastfeeding rates at discharge days of life at full oral feeding breastfeeding rates at discharge

  at discharge

Study Arms (2)

A,1

EXPERIMENTAL

Cup feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup

Procedure: cup feeding

A,2

ACTIVE COMPARATOR

bottle feeding - conventional method Bottle feeding is the conventional method to feed preterm infant before breastfeeding or to substitute breastfeeding. We are using this method in the control group.

Procedure: bottle feeding

Interventions

cup feeding PROCEDURE

Method to feed: cup. This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup

Also known as: cup method

A,1

bottle feeding PROCEDURE

bottle feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using bottle

Also known as: bottle

A,2

Eligibility Criteria

• Age: 29 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• very low birthweight
• gestational age from 26 to 32 complete weeks
• absence of congenital anomalies in the face, head and neck
• absence of severe asphyxia
• negative serology for AIDS
• mothers willing to breastfeed
• absence of pulmonary disease

You may not qualify if:

• severe intraventricular hemorrhage
• necrotizing enterocolitis
• infection after the beginning of the trial

Sponsors & Collaborators

• Instituto Fernandes Figueira: lead

Study Sites (1)

Instituto Fernandes Figueira

Rio de Janeiro, Rio de Janeiro, 22250020, Brazil

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Maria Elisabeth l Moreira, PhD

  Instituto Fernandes Figueira

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: June 24, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

BR (1)