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

Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838188
• Other study ID #: 920060356
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: February 5, 2009
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: February 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 34 Weeks to 40 Weeks

Eligibility

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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

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

Locations

Country	Name	City	State
Israel	Department of Neonatology, Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured		Not relevant	No