Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding
Primary Purpose
Infant, Very Low Birth Weight
Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
cup feeding
bottle feeding
Sponsored by
About this trial
This is an interventional supportive care trial for Infant, Very Low Birth Weight focused on measuring Sucking patterns, preterm infants, breastfeeding
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- severe intraventricular hemorrhage
- necrotizing enterocolitis
- infection after the beginning of the trial
Sites / Locations
- Instituto Fernandes Figueira
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A,1
A,2
Arm Description
Cup feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup
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.
Outcomes
Primary Outcome Measures
Temporal parameters of sucking
Secondary Outcome Measures
days of life at full oral feeding; breastfeeding rates at discharge days of life at full oral feeding breastfeeding rates at discharge
Full Information
NCT ID
NCT00703950
First Posted
April 2, 2008
Last Updated
August 10, 2015
Sponsor
Instituto Fernandes Figueira
1. Study Identification
Unique Protocol Identification Number
NCT00703950
Brief Title
Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding
Official Title
Effects of the Use of a Bottle and a Cup on Breast Sucking Patterns of Premature Infants: Safety and Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Sample size was re- calculated considering sucking pattern parameters
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Fernandes Figueira
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Breastfeeding is the better method to promote adequate growth and development in preterm infants. However, sometimes preterm infants needs to be supplemented with the own mother milk or formula using another methods.
The cup and the bottle have been used in neonatal units, however there is still no evidence to determine the best feeding method, which must be safe, efficient and not jeopardize breast feeding.
The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns. The intervention will be the use of bottle or cup to feed preterm infants before or to supplement breastfeeding after randomization. Nowadays, bottle feeding is the conventional method and we wish to compare sucking patterns after use of bottle or cup. As secondary endpoints, weight gain, days of life to begin full oral feeding, length of hospital stay and breast feeding rates will be observed. In order to achieve this aim, a blind randomized clinical trial will be done with 96 very low birth weight infants, in which a group is randomly selected to be breast fed and get supplementary food using a cup and another to get supplementary food using a bottle.
The trial's inclusion criteria are: birth weight < 1500 g (very low birth weight infants), gestational age from 26 to 32 full weeks, absence of congenital anomalies in the face, head and neck, without severe asphyxia (Apgar < 5 on the 5th minute), negative tests for AIDS, absence of pulmonary chronic disease, mothers willing to breastfeed. Exclusion criteria are: intraventricular hemorrhage (degree III or IV), necrotizing enterocolitis, infection after the beginning of the trial.
Once all newborns in the trial were clinically stable (normal blood pressure without needs of oxygen) and with a volume intake of at least 100 ml/Kg/day of milk through the orogastric tube, they will receive oral-motor stimulation through a stimulation program previously published (2002). Once the newborn meets the criteria to begin oral feeding, an instrumental assessment of non-nutritive sucking and nutritive sucking will be carried out. Intra-oral pressure is assessed in non-nutritive sucking using a pressure monitoring device in a gloved finger: intra-oral negative pressure will be registered using a pressure transducer inserted through a catheter to the tip of the gloved little finger. This catheter will be connected to a second pressure transducer. Simultaneously, breathing (respiratory flow) will be measured using a pneumotachograph coupled to a nasal Prong. Two minutes of sucking will be collected from the moment the newborn responds to the search reflex and grabs the finger. During nutritive sucking assessment, respiration (respiratory flow) will be measured using a pneumotachograph coupled to a nasal Prong. At the same time intra-oral sucking pressure will be recorded by a pressure transducer connected to a catheter located on the mother's breast. Nutritive sucking will take place in the first 5 minutes of breastfeeding. After the first assessment has been concluded, the newborn will be randomly assigned either to the group that will use a cup or a bottle for supplementary feeding using randomized block design. Assessments will be repeated at discharge from the hospital.
The study is taking place at Fernandes Figueira Institute and was approved by the Institutional Review Board.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Very Low Birth Weight
Keywords
Sucking patterns, preterm infants, breastfeeding
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A,1
Arm Type
Experimental
Arm Description
Cup feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup
Arm Title
A,2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
cup feeding
Other Intervention Name(s)
cup method
Intervention Description
Method to feed: cup. This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using cup
Intervention Type
Procedure
Intervention Name(s)
bottle feeding
Other Intervention Name(s)
bottle
Intervention Description
bottle feeding This is a method to feed preterm babies when breastfeeding is impossible. Feed is provided using bottle
Primary Outcome Measure Information:
Title
Temporal parameters of sucking
Time Frame
at discharge
Secondary Outcome Measure Information:
Title
days of life at full oral feeding; breastfeeding rates at discharge days of life at full oral feeding breastfeeding rates at discharge
Time Frame
at discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
29 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
severe intraventricular hemorrhage
necrotizing enterocolitis
infection after the beginning of the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisabeth l Moreira, PhD
Organizational Affiliation
Instituto Fernandes Figueira
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Fernandes Figueira
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22250020
Country
Brazil
12. IPD Sharing Statement
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Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding
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