Breast Milk CollectionNCT04450056
Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants
An observational study of Breast Milk Collection and Infant Development, run by Aga Khan University at 1 site in Pakistan.
Trial summary
In Pakistan, breastfeeding is widely practiced. National data suggests that 94% of infants <2 years of age receive breastmilk at some point. However, the introduction of complementary foods often occurs early. At 3 months of age, it is suggested that only 54% of Pakistani infants are exclusively breastfed. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women only
- Conditions the study is for
- Breast Milk Collection, Infant Development
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2020to Dec 2020
- 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 15 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Mothers and infants enrolled in the MaPPS Trial in Matiari District, Pakistan.
Who may be able to join
- Enrolled in the MaPPS Trial
- Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
- The infant must be term-born (>37 weeks gestation)
- Infant must be 1 month + 14 days old at the time of recruitment
- Mothers must be willing to provide a complete breastmilk expression from one breast (either via breast pump or hand expression)
- Able to provide informed consent
Who cannot join
- Mother reports mixed feeding of her infant with nutritive feeds (i.e., any provision of formula or animal milk)
- The infant was born preterm (earlier than 37 weeks gestation)
- Mother does not wish to provide a complete breast expression of one breast
Trial locations and contacts
1 site in 1 country.
About this study
In Pakistan, breastfeeding is widely practiced. National data suggests that 94% of infants <2 years of age receive breastmilk at some point. However, the introduction of complementary foods often occurs early. At 3 months of age, it is suggested that only 54% of Pakistani infants are exclusively breastfed. This declines with each month of age. Because the production and release of breastmilk is influenced by the frequency and intensity of suckling, early initiation of complementary feeding can reduce breastmilk output. Given that complementary foods are introduced early within Pakistan, we hypothesize that breastmilk composition will change between 1 and 3 months postpartum among those mother-infant pairs if nutritive complementary foods are introduced early (i.e., before 6 months). In this study, we aim to better understand how breastmilk composition changes over time among infants recruited at 1 month of age who are exclusively breastfed or receive only non-nutritive feeds. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).
- Conditions
- Breast Milk Collection, Infant Development
- Being tested
- No intervention
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Mother-infant pairs | Mothers with a term-born (>37 weeks gestation) infant whom they are exclusively or predominantly breastfeeding at 1 month postpartum. Mothers must be enrolled in the MaPPS Trial (ClinicalTrials.gov Identifier: NCT03287882). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breastmilk macronutrient composition
Measured: 1 and 3 months postpartum
Change in breastmilk micronutrient composition
Measured: 1 and 3 months postpartum
Secondary outcomes (3)
Change in breastmilk bioactive composition
Measured: 1 and 3 months postpartum
Change in breastmilk microbiome
Measured: 1 and 3 months postpartum
Change in infant microbiome
Measured: 1 and 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start5 Aug 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Milk CollectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450056
- Sponsor's protocol ID
- 2020-3676-10314b
- Status last verified
- Nov 2020
- First submitted
- 22 Jun 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact the Primary Investigator directly for more details.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Changes in Breastmilk Composition Over Time Among Pakistani Infants
- ClinicalTrials.gov ID
- NCT04450056
- Acronym / sponsor ID
- 2020-3676-10314b
- Conditions
- Breast Milk Collection, Infant Development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, University of Toronto
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 29 Jun 2020 (actual)
- 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.
In Pakistan, breastfeeding is widely practiced. National data suggests that 94% of infants <2 years of age receive breastmilk at some point. However, the introduction of complementary foods often occurs early. At 3 months of age, it is suggested that only 54% of Pakistani infants are exclusively breastfed. This declines with each month of age. Because the production and release of breastmilk is influenced by the frequency and intensity of suckling, early initiation of complementary feeding can reduce breastmilk output. Given that complementary foods are introduced early within Pakistan, we hypothesize that breastmilk composition will change between 1 and 3 months postpartum among those mother-infant pairs if nutritive complementary foods are introduced early (i.e., before 6 months). In this study, we aim to better understand how breastmilk composition changes over time among infants recruited at 1 month of age who are exclusively breastfed or receive only non-nutritive feeds. This is a substudy to the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial (ClinicalTrials.gov Identifier: NCT03287882).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother-infant pairs | – | Other: No interventionMothers with a term-born (>37 weeks gestation) infant whom they are exclusively or predominantly breastfeeding at 1 month postpartum. Mothers must be enrolled in the MaPPS Trial (ClinicalTrials.gov Identifier: NCT03287882). |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Mothers and infants enrolled in the MaPPS Trial in Matiari District, Pakistan.
Key inclusion criteria (6 listed)
- Enrolled in the MaPPS Trial
- Mothers must report practicing exclusive or predominant breastfeeding (i.e., breastmilk only or breastmilk and non-nutritive feeds only)
- The infant must be term-born (>37 weeks gestation)
- Infant must be 1 month + 14 days old at the time of recruitment
- Mothers must be willing to provide a complete breastmilk expression from one breast (either via breast pump or hand expression)
Key exclusion criteria (3 listed)
- Mother reports mixed feeding of her infant with nutritive feeds (i.e., any provision of formula or animal milk)
- The infant was born preterm (earlier than 37 weeks gestation)
- Mother does not wish to provide a complete breast expression of one breast
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 |
|---|---|---|
| No interventionNo intervention | Other | Mother-infant pairs |
Primary outcome
Change in breastmilk macronutrient composition
Time frame: 1 and 3 months postpartum
Change in breastmilk micronutrient composition
Time frame: 1 and 3 months postpartum
3 secondary outcomes
Change in breastmilk bioactive composition
Time frame: 1 and 3 months postpartum
Change in breastmilk microbiome
Time frame: 1 and 3 months postpartum
Change in infant microbiome
Time frame: 1 and 3 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: Yes. Please contact the Primary Investigator directly for more details.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection and Infant Development, run by Aga Khan University at 1 site in Pakistan.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2020. 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 Pakistan. 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?
Results are not available in the source record.
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?
Change in breastmilk macronutrient composition (time frame: 1 and 3 months postpartum). The study lists 2 primary outcomes in all. 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 18 Nov 2020; AzTrials last refreshed its copy on 31 Oct 2026.