Preterm InfantsNCT00838188
Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
An observational study of Preterm Infants, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 34 to 40 weeks
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Way of Feeding - Breast feeding vs. Bottle feeding
- How many people
- 23 participants
- Where
- 2 sitesIsrael
- Study dates
- Nov 2007to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants born after 32 weeks of gestation, when they reached the corrected gestational age of 34 weeks or more.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Department of Neonatology, Tel Aviv Sourasky Medical Center
Tel Aviv
Sourasky Medical Center
Tel Aviv
About this study
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.
Read the 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
- Conditions
- Preterm Infants
- Being tested
- Way of Feeding - Breast feeding vs. Bottle feeding
- Keywords
- Metabolic rate, indirect calorimetry, oral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Way of Feeding - Breast feeding vs. Bottle feedingOther
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 | Role | What they receive |
|---|---|---|
| 1 | computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence Receives: Other: Way of Feeding - Breast feeding vs. Bottle feeding | |
| 2 | computer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence Receives: 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 Receives: 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 Receives: 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 Receives: Other: Way of Feeding - Breast feeding vs. Bottle feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Not relevant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2009 (estimated)
- Study startNov 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Irit Berger, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00838188
- Sponsor's protocol ID
- 920060356
- Status last verified
- Feb 2009
- First submitted
- 5 Feb 2009
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1542/peds.2009-0165. Epub 2009 Nov 23.
PubMed 19933725
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk
- ClinicalTrials.gov ID
- NCT00838188
- Acronym / sponsor ID
- 920060356
- Conditions
- Preterm Infants
- Keywords
- Metabolic rate, indirect calorimetry, oral feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2007
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Way of Feeding - Breast feeding vs. Bottle feedingcomputer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence |
| 2 | – | Other: Way of Feeding - Breast feeding vs. Bottle feedingcomputer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence |
| Breast - feeding first | – | Other: Way of Feeding - Breast feeding vs. Bottle feedingcomputer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence |
| Bottle first | – | Other: Way of Feeding - Breast feeding vs. Bottle feedingcomputer-generated random numbers in sealed opaque envelopes to assign the breast/bottle sequence |
| Way of feeding | – | Other: Way of Feeding - Breast feeding vs. Bottle feedingEach 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 |
Who may qualify
- Ages
- 34 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants born after 32 weeks of gestation, when they reached the corrected gestational age of 34 weeks or more.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Way of Feeding - Breast feeding vs. Bottle feedingEach 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 | Other | 1, 2, Bottle first, Breast - feeding first, Way of feeding |
Primary outcome
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
1 secondary outcome
Creamatocrit of the bottle at the beginning and the completion of every feeding at the breast were measured
Time frame: Not relevant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
- Derived from this study: PubMed 19933725Berger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irit Berger, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Infants, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00838188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009.