Breast FeedingNCT02016586
Breastfeeding Intervention Study
A study testing Maternal Nutritional Supplement in people with Breast Feeding, run by Abbott Nutrition at 18 sites in Vietnam.
Trial summary
To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Maternal Nutritional Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 18 sitesVietnam
- Study dates
- Nov 2013to May 2015
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mother with singleton pregnancy at 26 to 29 weeks of gestation.
- Mother is between 20 and 35 years of age.
- Mother pre-pregnant BMI < 25.0 kg/m2.
- Mother is first-time mother.
- Mother is contactable by telephone.
- Mother is non-smoker.
Show all 10Show fewer
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- Infant's birth weight was > 2500 g.
- Infant is judged to be in good health.
- Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period.
Who cannot join
- Mother is allergic or intolerant to any ingredient found in the study product.
- An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development.
- Mother has gestational diabetes and/or pre-eclampsia.
- Mother with contraindications to breastfeeding.
- Gestational weight gain is greater than 14 kg at enrollment.
- Mother had a breast surgery.
- Mother and/or newborn infant has major illness that requires intensive care admission.
- Infant has major congenital anomaly.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Vietnam18 sites
Bin Luc District Health Centre- Dong Du
Hà Nam
Binh Luc District Health Center - An Lao
Hà Nam
Binh Luc District Health Center - Binh Nghia
Hà Nam
Binh Luc District Health Center - Trang An
Hà Nam
An Lao District Health Center - Bat Trang
Haiphong
An Lao District Health Center - Quoc Tuan
Haiphong
An Lao District Health Center - Thai Son
Haiphong
An Lao District Health Centre- Quoc Trung
Haiphong
An Lao District Health Centre- Truang Tho
Haiphong
Yen Mo District Health Center - Yen Dong
Ninh Bình
Yen Mo District Health Center - Yen Hoa
Ninh Bình
Yen Mo District Health Center - Yen Thanh
Ninh Bình
Phu Binh District Health Center - Kha Son
Thai Nguyen
Phu Binh District Health Center - Tan Khanh
Thai Nguyen
Phu Binh District Health Center - Tan Kim
Thai Nguyen
Phu Binh District Health Centre- Tan Duc
Thai Nguyen
Phu Binh District Health Centre- Tan Hoa
Thai Nguyen
Phu Binh District Health Centre- Xuan Phuong
Thai Nguyen
About this study
To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.
Read the detailed description
This study aims to evaluate the benefits of a lactation support intervention model combining a maternal nutritional supplementation starting at 8 weeks before delivery to 12 weeks postpartum and a lactation support intervention consisting of 1 prenatal and 3 postnatal sessions on exclusive breastfeeding rate.
- Conditions
- Breast Feeding
- Being tested
- Maternal Nutritional Supplement
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Nutritional SupplementDietary supplement
S348S0
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects in the control group will continue to take the prenatal supplement primarily consisting of folic acid (400 mcg), elemental iron (60 mg) and will receive breastfeeding advice during prenatal visits. |
| Intervention | Experimental | Lactation support in conjunction with a maternal nutritional supplement S348S0 Receives: Dietary Supplement: Maternal Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Rate
Measured: Week 12 postpartum
Secondary outcomes (8)
Breastfeeding Rate
Measured: Week 4 postpartum
Lactation Assessment
Maternal completed questionnaire with visual analogue scales
Measured: Week 4 postpartum
Infant Anthropometrics
Scale weight; Length and head circumference measurement
Measured: Week 4 postpartum
Breastfeeding Rate
Measured: Week 8 postpartum
Lactation Assessment
Maternal completed questionnaire with visual analogue scales
Measured: Week 8 postpartum
Lactation Assessment
Maternal completed questionnaire with visual analogue scales
Measured: Week 12 postpartum
Infant Anthropometrics
Scale weight; Length and head circumference measurement
Measured: Week 8 postpartum
Infant Anthropometrics
Scale weight; Length and head circumference measurement
Measured: Week 12 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionMay 2015
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 Breast FeedingStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dieu Huynh, MD, PhD., Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016586
- Sponsor's protocol ID
- AL08
- Status last verified
- May 2016
- First submitted
- 29 Nov 2013
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tran NT, Nguyen LT, Berde Y, Low YL, Tey SL, Huynh DTT. Maternal nutritional adequacy and gestational weight gain and their associations with birth outcomes among Vietnamese women. BMC Pregnancy Childbirth. 2019 Dec 4;19(1):468. doi: 10.1186/s12884-019-2643-6.
PubMed 31801514
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Intervention Study
- ClinicalTrials.gov ID
- NCT02016586
- Acronym / sponsor ID
- AL08
- Conditions
- Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Dec 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.
To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.
Detailed description
This study aims to evaluate the benefits of a lactation support intervention model combining a maternal nutritional supplementation starting at 8 weeks before delivery to 12 weeks postpartum and a lactation support intervention consisting of 1 prenatal and 3 postnatal sessions on exclusive breastfeeding rate.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects in the control group will continue to take the prenatal supplement primarily consisting of folic acid (400 mcg), elemental iron (60 mg) and will receive breastfeeding advice during prenatal visits. |
| Intervention | Experimental | Dietary Supplement: Maternal Nutritional SupplementLactation support in conjunction with a maternal nutritional supplement S348S0 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Mother with singleton pregnancy at 26 to 29 weeks of gestation.
- Mother is between 20 and 35 years of age.
- Mother pre-pregnant BMI < 25.0 kg/m2.
- Mother is first-time mother.
- Mother is contactable by telephone.
Key exclusion criteria (8 listed)
- Mother is allergic or intolerant to any ingredient found in the study product.
- An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development.
- Mother has gestational diabetes and/or pre-eclampsia.
- Mother with contraindications to breastfeeding.
- Gestational weight gain is greater than 14 kg at enrollment.
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 |
|---|---|---|
| Maternal Nutritional SupplementS348S0 | Dietary supplement | Intervention |
Primary outcome
Breastfeeding Rate
Time frame: Week 12 postpartum
8 secondary outcomes
Breastfeeding Rate
Time frame: Week 4 postpartum
Lactation Assessment
Time frame: Week 4 postpartum
Infant Anthropometrics
Time frame: Week 4 postpartum
Breastfeeding Rate
Time frame: Week 8 postpartum
Lactation Assessment
Time frame: Week 8 postpartum
Lactation Assessment
Time frame: Week 12 postpartum
Infant Anthropometrics
Time frame: Week 8 postpartum
Infant Anthropometrics
Time frame: Week 12 postpartum
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 24 May 2016.
- Derived from this study: PubMed 31801514Tran NT, Nguyen LT, Berde Y, Low YL, Tey SL, Huynh DTT. Maternal nutritional adequacy and gestational weight gain and their associations with birth outcomes among Vietnamese women. BMC Pregnancy Childbirth. 2019 Dec 4;19(1):468. doi: 10.1186/s12884-019-2643-6.
- Individual participant dataSharing planned: No
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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.
Dieu Huynh, MD, PhD. study chair
Abbott Nutrition
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Nutritional Supplement in people with Breast Feeding, run by Abbott Nutrition at 18 sites in Vietnam.
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 10 inclusion and 8 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 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Vietnam. 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?
Breastfeeding Rate (time frame: Week 12 postpartum). 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 NCT02016586, 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 24 May 2016.