Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 5, 2009 | ||||
| Last Updated Date | February 5, 2009 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk | ||||
| Official Title ICMJE | Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk | ||||
| 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. |
||||
| 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 |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Crossover Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Maternal breast milk |
||||
| 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. |
||||
| Condition ICMJE | Preterm Infants | ||||
| Intervention ICMJE | 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 |
||||
| Study Group/Cohort (s) |
|
||||
| Publications * | 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. Epub 2009 Nov 23. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 23 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 34 Weeks to 40 Weeks | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00838188 | ||||
| Other Study ID Numbers ICMJE | 920060356 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Irit berger Dr., Tel-Aviv Sourasky Medical Center | ||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||
| Verification Date | February 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||