PrematurityNCT01802047
Impact of Different Electric Pumping Modalities on Milk Volume Production in Mothers of Preterm Infants
A study testing milk expression with electric pump in people with Prematurity, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Initiating and sustaining breastfeeding are common challenges in neonatal units. It is known that hindmilk expressed at the end of the expression session has a higher fat content. Previous studies have shown that simultaneous pumping is more effective at producing milk than sequential pumping. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Prematurity
- What is being tested?
- milk expression with electric pump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2013to Dec 2018
- 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
- Mothers of Preterms
Who cannot join
- HIV infected mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities
Initiating and sustaining breastfeeding are common challenges in neonatal units.
It is known that hindmilk expressed at the end of the expression session has a higher fat content.
Previous studies have shown that simultaneous pumping is more effective at producing milk than sequential pumping. However this approach is often felt uncomfortable by the mothers, and sequential pumping is preferred.
The purpose of this study is to determine which modality of milk expression by electric pump is the most efficient and productive when sequential pumping is used.This is done by assessing the milk volume expressed per expression and its macronutrients content.
Read the detailed description
The study will last for 6 days. Each mother will express breast milk following two designed modalities in a random fashion, for two days each.
The two designed modalities are:
- Complete pumping of one breast (first left) for 15 min, followed by complete pumping of the right breast for 15 min, until the breast is empty.
- Pumping both breast simultaneously for 15 min.
At day one of the study, the mothers will follow the standard pumping modality in practice at our department.
In between the two studied procedures at day 4 of the study, the mothers will again follow the standard pumping modality.
On each day of the study, in the morning after the first expression of the day, a sample of 2 ml of pumped breastmilk will be taken, and the total volume of the daily expressed milk will be recorded.
- Conditions
- Prematurity
- Being tested
- milk expression with electric pump
- Keywords
- Mothers of Preterms, Breastfeeding Mothers of Preterm infants, mother milk feeding
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk expression with electric pumpProcedure or surgery
Also called Medella Electric breast pump
| Study group | Role | What they receive |
|---|---|---|
| Electric Pump Modality | Experimental | Each mother follows all 3 electric pump modalities in a randomized order. Receives: Procedure: milk expression with electric pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily volume of expressed breast milk under a specific electric pumping modality
The total volume of all milk expression sessions of the day will be recorded. This, for each 6 days of the study.
Measured: after 15 minutes of electric expression of each breast
Secondary outcomes (1)
Composition of expressed milk under a specific electric pumping modality
Fat, Protein and Carbohydrate concentrations will be assessed after each morning session of milk expression by using the mid-infrared milk analyzer (Miris AB, Uppsala, Sweden)
Measured: after the first morning session of electric milk expression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: d/t changes in routine modality of milk expression by electric pump.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shaul Dollberg, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802047
- Sponsor's protocol ID
- TASMC-13-SD-0678-12-CTIL
- Status last verified
- Mar 2016
- First submitted
- 19 Feb 2013
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities
- ClinicalTrials.gov ID
- NCT01802047
- Acronym / sponsor ID
- TASMC-13-SD-0678-12-CTIL
- Conditions
- Prematurity
- Keywords
- Mothers of Preterms, Breastfeeding Mothers of Preterm infants, mother milk feeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: d/t changes in routine modality of milk expression by electric pump.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Mar 2013 (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.
Initiating and sustaining breastfeeding are common challenges in neonatal units.
It is known that hindmilk expressed at the end of the expression session has a higher fat content.
Previous studies have shown that simultaneous pumping is more effective at producing milk than sequential pumping. However this approach is often felt uncomfortable by the mothers, and sequential pumping is preferred.
The purpose of this study is to determine which modality of milk expression by electric pump is the most efficient and productive when sequential pumping is used.This is done by assessing the milk volume expressed per expression and its macronutrients content.
Detailed description
The study will last for 6 days. Each mother will express breast milk following two designed modalities in a random fashion, for two days each.
The two designed modalities are:
- Complete pumping of one breast (first left) for 15 min, followed by complete pumping of the right breast for 15 min, until the breast is empty.
- Pumping both breast simultaneously for 15 min.
At day one of the study, the mothers will follow the standard pumping modality in practice at our department.
In between the two studied procedures at day 4 of the study, the mothers will again follow the standard pumping modality.
On each day of the study, in the morning after the first expression of the day, a sample of 2 ml of pumped breastmilk will be taken, and the total volume of the daily expressed milk will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electric Pump Modality | Experimental | Procedure: milk expression with electric pumpEach mother follows all 3 electric pump modalities in a randomized order. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mothers of Preterms
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 |
|---|---|---|
| milk expression with electric pumpAlso: Medella Electric breast pump | Procedure or surgery | Electric Pump Modality |
Primary outcome
Daily volume of expressed breast milk under a specific electric pumping modality
Time frame: after 15 minutes of electric expression of each breast
The total volume of all milk expression sessions of the day will be recorded. This, for each 6 days of the study.
1 secondary outcome
Composition of expressed milk under a specific electric pumping modality
Time frame: after the first morning session of electric milk expression
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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 Dollberg, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk expression with electric pump in people with Prematurity, 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: withdrawn, as of the sponsor's last update on 29 Mar 2016. 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 was withdrawn before enrolling participants, so there are no results.
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?
Daily volume of expressed breast milk under a specific electric pumping modality (time frame: after 15 minutes of electric expression of each breast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2016.