InfantNCT02366780
Breast Milk Content Expressed Manually Compared to Electric Pump
A study testing Pump in people with Infant, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Infant
- What is being tested?
- Pump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2012to Aug 2014
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy lactating mothers of term infants
Who cannot join
- HIV infected mothers
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Neonatology, Lis Maternity Hospital, Tel Aviv medical Center
Tel Aviv, 64239
About this study
Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors.
Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast.
Read more
Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown.
The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.
- Conditions
- Infant
- Being tested
- Pump
- Keywords
- Lactation, Breastmilk, Macronutrients
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PumpProcedure or surgery
Breast milk expression using manually or using an electric pump
| Study group | Role | What they receive |
|---|---|---|
| Manual expression followed by electric pump | Experimental | Mothers will be assigned to first express breast milk manually followed by electric pump Receives: Procedure: Pump |
| Electric pump followed by manual expression | Experimental | Mothers will be assigned to first express breast milk by electric pump followed by manual expression Receives: Procedure: Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macronutrient content of expressed breast milk
Mothers will express milk from the same breast indicated in the assigned arm. Macronutrient content will be analyzed using the Human Milk Analyzer
Measured: 3 to 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
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 InfantStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shaul Dolberg, MD, Principal investigator, Department of Pediatrics, Sakler Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366780
- Sponsor's protocol ID
- SD-0662-11-TLV
- Status last verified
- Sep 2015
- First submitted
- 4 Feb 2015
- Last updated
- 3 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mangel L, Ovental A, Batscha N, Arnon M, Yarkoni I, Dollberg S. Higher Fat Content in Breastmilk Expressed Manually: A Randomized Trial. Breastfeed Med. 2015 Sep;10(7):352-4. doi: 10.1089/bfm.2015.0058. Epub 2015 Jul 14.
PubMed 26171639
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Milk Content Expressed Manually Compared to Electric Pump
- ClinicalTrials.gov ID
- NCT02366780
- Acronym / sponsor ID
- SD-0662-11-TLV
- Conditions
- Infant
- Keywords
- Lactation, Breastmilk, Macronutrients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Feb 2015 (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.
Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors.
Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast.
Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown.
The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual expression followed by electric pump | Experimental | Procedure: PumpMothers will be assigned to first express breast milk manually followed by electric pump |
| Electric pump followed by manual expression | Experimental | Procedure: PumpMothers will be assigned to first express breast milk by electric pump followed by manual expression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy lactating mothers of term infants
Key exclusion criteria (1 listed)
- HIV infected mothers
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 |
|---|---|---|
| PumpBreast milk expression using manually or using an electric pump | Procedure or surgery | Electric pump followed by manual expression, Manual expression followed by electric pump |
Primary outcome
Macronutrient content of expressed breast milk
Time frame: 3 to 5 min
Mothers will express milk from the same breast indicated in the assigned arm. Macronutrient content will be analyzed using the Human Milk Analyzer
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 3 Sep 2015.
- Results publication: PubMed 26171639Mangel L, Ovental A, Batscha N, Arnon M, Yarkoni I, Dollberg S. Higher Fat Content in Breastmilk Expressed Manually: A Randomized Trial. Breastfeed Med. 2015 Sep;10(7):352-4. doi: 10.1089/bfm.2015.0058. Epub 2015 Jul 14.
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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.
Shaul Dolberg, MD principal investigator
Department of Pediatrics, Sakler Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pump in people with Infant, run by Tel-Aviv Sourasky Medical Center at 1 site 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 1 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 3 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Macronutrient content of expressed breast milk (time frame: 3 to 5 min). 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 NCT02366780, 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 3 Sep 2015.