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Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk

This study has been completed.
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00838188
First received: February 5, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Preterm Infants
 Other: Way of Feeding - Breast feeding vs. Bottle feeding

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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 [ Time Frame: 20 minutes after each meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured [ Time Frame: Not relevant ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Maternal breast milk


Enrollment: 23
Study Start Date: November 2007
Study Completion Date: March 2008
Groups/Cohorts Assigned Interventions
1
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
 Other: Way of Feeding - Breast feeding vs. Bottle feeding
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
2
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
 Other: Way of Feeding - Breast feeding vs. Bottle feeding
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
Breast - feeding first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
 Other: Way of Feeding - Breast feeding vs. Bottle feeding
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
Bottle first
computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence
 Other: Way of Feeding - Breast feeding vs. Bottle feeding
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
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
 Other: Way of Feeding - Breast feeding vs. Bottle feeding
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

Detailed Description:

Most VLBW infants cannot be fed at the breast upon birth, and expressed breast milk by gastric tube is thus recommended. Sucking skills mature at around 34 weeks when nipple-feeding is introduced. In the absence of evidence-based data to decide the best timing to introduce breastfeeding, many clinicians use empiric criteria, such as the infant's weight, gestational age, and the ability of infants to bottle feed as proxies of readiness to breastfeed. Despite some evidence of physiological benefits of preterm infants feeding at the breast, many neonatologists consider direct breastfeeding to be too fatiguing for preterm infants. It is not known, however, whether preterm infants who are breastfed expend more energy than bottle-fed infants

  Eligibility

Ages Eligible for Study:   34 Weeks to 40 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Preterm infants born after 32 weeks of gestation, when they reached the corrected gestational age of 34 weeks or more.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838188

Locations
Israel
Department of Neonatology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Irit Berger, MD
  More Information

No publications provided by Tel-Aviv Sourasky Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Irit berger Dr., Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00838188     History of Changes
Other Study ID Numbers: 920060356
Study First Received: February 5, 2009
Last Updated: February 5, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Metabolic rate
indirect calorimetry
oral feeding

ClinicalTrials.gov processed this record on May 23, 2013