NCT00838188

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2009

Completed
Last Updated

February 6, 2009

Status Verified

February 1, 2009

First QC Date

February 5, 2009

Last Update Submit

February 5, 2009

Conditions

Keywords

Metabolic rateindirect calorimetryoral feeding

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

Other: Way of Feeding - Breast feeding vs. Bottle feeding

2

computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence

Other: Way of Feeding - Breast feeding vs. Bottle feeding

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

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

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

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

12Bottle firstBreast - feeding firstWay of feeding

Eligibility Criteria

Age34 Weeks - 40 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal breast milk

Study Officials

  • Irit Berger, MD

    PRINCIPAL INVESTIGATOR

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

Locations