Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
1 other identifier
observational
23
1 country
2
Brief Summary
OBJECTIVE. Neonatologists consider early feeding at the breast to be too tiring for preterm infants, although there is no evidence that this is actually the case. It is also not known whether the method of feeding affects energy expenditure. We hypothesized that resting energy expenditure (REE) would be higher after breastfeeding than after bottle feeding. PATIENTS AND METHODS. preterm ( \>32 weeks GA) stable infants who are nourished entirely by their mothers' breast milk will be studied when fed expressed breast milk either by bottle or at the breast. REE will be measured for 20 minutes after feeding. Breast milk quantity is evaluated by pre- and post feeding weighing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2007
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 6, 2009
CompletedFebruary 6, 2009
February 1, 2009
February 5, 2009
February 5, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary goal of this study was to compare resting energy expenditure (REE) in preterm infants who were fed their mothers' expressed milk by bottle and at the breast
20 minutes after each meal
Secondary Outcomes (1)
Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured
Not relevant
Study Arms (5)
1
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
2
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Breast - feeding first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Bottle first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Way of feeding
Each infant is evaluated twice, once after breastfeeding and once after bottle feeding of breast milk using a Premature Nipple \& Ring (Ross Products Division, Columbus OH, USA). In this way, each infant serves as its own control. REE is recorded for 20 minutes after each meal
Interventions
Each infant was evaluated twice, once after breastfeeding and once after bottle feeding of breast. Computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
Eligibility Criteria
Preterm infants born after 32 weeks of gestation, when they reached the corrected gestational age of 34 weeks or more.
You may qualify if:
- Thermally stable infants were nursed in an open and unwarmed bassinet.
- All fed solely by their mothers' breast milk equivalent to at least 150 cc/kg/day divided into eight meals and growing steadily
You may not qualify if:
- Infants with congenital anomalies and infants who had either more than five daily episodes of apnea of prematurity or any apnea requiring assistance or methylxanthine therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Neonatology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sourasky Medical Center
Tel Aviv, Israel
Related Publications (1)
Berger I, Weintraub V, Dollberg S, Kopolovitz R, Mandel D. Energy expenditure for breastfeeding and bottle-feeding preterm infants. Pediatrics. 2009 Dec;124(6):e1149-52. doi: 10.1542/peds.2009-0165. Epub 2009 Nov 23.
PMID: 19933725DERIVED
Biospecimen
Maternal breast milk
Study Officials
- PRINCIPAL INVESTIGATOR
Irit Berger, MD
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 5, 2009
First Posted
February 6, 2009
Study Start
November 1, 2007
Study Completion
March 1, 2008
Last Updated
February 6, 2009
Record last verified: 2009-02