Human MilkREFINENCT04041505
Responsive Feeding of Infants With Expressed Milk
A study testing (feeding modality) in people with Human Milk and Breastfeeding, run by Mount Saint Vincent University at 1 site in Canada.
Trial summary
Nova Scotia has among the lowest breastfeeding rates in Canada, with less than one quarter of infants receiving Health Canada's recommended 6 months of exclusive breastfeeding. Compared with feeding formula, breastfeeding has been linked with a number of health advantages, including fewer infections, higher IQ, and a… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Milk, Breastfeeding, Feeding Behavior
- What is being tested?
- (feeding modality)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2019to 30 Mar 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria: Mother-infant dyads are eligible to participate if:
- mother is aged 19 years or older,
- dyads currently live in the Halifax Regional Municipality in Nova Scotia,
- mother has no chronic diseases,
- the baby is a healthy singleton baby who is younger than 6 weeks of age, and is fed mother's milk directly from the breast and from a bottle,
- mother plans to exclusively feed their baby mother's own milk up to 6 months,
- mother has/had an older child whom they successfully fed mother's own milk for a minimum of 6 months,
- mother is willing to participate in three 3-day study sessions and monthly measurement sessions, and
- mother provides informed consent for herself and her infant to participate.
Exclusion criteria: Mother-infant dyads are ineligible to participate if:
- the baby was born preterm (earlier than 37 weeks gestation),
- the baby was born outside the healthy weight range of 2,500 - 4,000 g (5lb 8oz to 8lb 13oz),
- the baby has a developmental delay diagnosed before the time of enrolment,
- the baby is currently receiving any medical treatment except for vitamin D supplementation (no more than 400 IU/day),
- the mother sought prescription medical treatment for lactation (e.g. domperidone, antibiotics, prescription nipple ointment), or
- the mother plans to move in the 6 months after starting the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
MAMA Lab, Mount Saint Vincent University
Halifax, Nova Scotia, B3M2J6
About this study
Official title: Feeding Infants in Nova Scotia: an Exploratory Analysis of Responsive Feeding With Mother's Milk
Nova Scotia has among the lowest breastfeeding rates in Canada, with less than one quarter of infants receiving Health Canada's recommended 6 months of exclusive breastfeeding. Compared with feeding formula, breastfeeding has been linked with a number of health advantages, including fewer infections, higher IQ, and a lowered risk of obesity later in life.
How infants consume human milk is changing. Pumping milk has grown in popularity in recent years because some mothers may feel stigmatized breastfeeding, especially in public, but also because it allows other caregivers to help with feeding. Although pumped human milk is considered equal to breastfeeding, there is very little research in this area, especially around responsive feeding and later health outcomes. Since pumped milk is fed from a bottle, the health benefits may be lost (for instance, this may impact a baby's ability to understand if s/he is hungry or full).
Read more
The primary aim of this study is to determine if the volume of human milk an infant consumes differs if they consume milk from a bottle versus the breast. The investigators will conduct a cross-over trial in which 62 mother-infant pairs will be randomized to feed at the breast or from a bottle for 24 hours, have a 24 hour wash-out period, and then 'cross-over' to another 24 hour session with the opposite 'treatment.' The volume of milk consumed at each feed within the 24 hour window (via indirect weighing, or weighing the baby before and after eating) will be recorded to determine if there are differences in milk consumption. Mother-infant pairs will complete this 3-day study three times, at 6 weeks, 4 months, and 6 months.
Information from this study will help to better understand current infant feeding practices in Nova Scotia, and the potential role this plays in future health outcomes. Evidence from this study may help to identify means of improving feeding practices and promoting human milk as the main food for Nova Scotian infants, setting them on a path for the best start in life.
Read the detailed description
See attached full protocol document for full details.
- Conditions
- Human Milk, Breastfeeding, Feeding Behavior
- Being tested
- (feeding modality)
- Keywords
- responsive feeding, expressing/pumping human milk
- Medical subject headings
- Breast Feeding, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(feeding modality)Behavioural
The intervention is a change in feeding modality: in both arms, infant's will consume mother's milk. The difference in arms is the modality in which human milk is consumed: either directly from the breast, or from a bottle.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding | Active comparator | Infant consumes mother's milk directly from the breast. Receives: Behavioral: (feeding modality) |
| Bottle-feeding | Experimental | Infant consumes mother's expressed milk from a bottle. Receives: Behavioral: (feeding modality) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of milk consumption
To assess if the volume of human milk consumed by infants differs by feeding modality (bottle feeding human milk versus breastfeeding), assessed as overall milk volume consumed over 24 hours, measured by indirect weighs at each feed during a 24-hour period.
Measured: 24 hours
Secondary outcomes (2)
Infant growth
To determine whether change in infant anthropometric measurements (length in cm, weight in kg, head circumference in cm) and growth rates (weight-for-age [WAZ], length-for-age [LAZ], weight-for-length [WLZ], BMI-for-age z-scores [BAZ]; all computed as z-scores) differ by self-reported usual feeding modality among infants exclusively consuming human milk.
Measured: Between 6 weeks and 6 months
Responsive feeding behaviors
To objectively assess responsiveness of infant feeding practices, both at the breast and during bottle-feeding of human milk, by video-recording feeding sessions in participant's homes.
Measured: Between 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start15 Aug 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Interim analysis (n=40 24-hr sessions) yielded biologically implausible data. We do not deem this novel, at-home, participant-led method prudent. Study will continue with only secondary objectives; primary objective (RCT) terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MilkStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a modified, randomized cross-over study. The 'intervention' in this study is simply feeding infants using one of two modalities that are already familiar to the mother and infant: feeding mother's milk from the breast and from a bottle. At each timepoint (6 weeks, 4 months, 6 months) infants will: be randomized using a balanced design (to control for order effect) to consume human milk from a bottle or from the breast for 24 hours; will then undergo a wash-out period in which they will be fed human milk as they usually would for 24 hours; then will complete the second 'treatment' (bottle or breast) for 24 hours. Due to the nature of the intervention, this study will not be blinded. We aim to recruit 62 mother-infant pairs (= 124 participants in total).
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Saint Vincent University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Prince Edward Island, Queen's University
- Responsible party
- Sponsor
- Investigators
- Kyly C Whitfield, PhD, Principal investigator, Mount Saint Vincent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041505
- Sponsor's protocol ID
- MSVUREB2018-155
- Acronym
- REFINE
- Status last verified
- May 2021
- First submitted
- 4 Jul 2019
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Infants in Nova Scotia: an Exploratory Analysis of Responsive Feeding With Mother's Milk
- ClinicalTrials.gov ID
- NCT04041505
- Acronym / sponsor ID
- REFINE / MSVUREB2018-155
- Conditions
- Human Milk, Breastfeeding, Feeding Behavior
- Keywords
- responsive feeding, expressing/pumping human milk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis (n=40 24-hr sessions) yielded biologically implausible data. We do not deem this novel, at-home, participant-led method prudent. Study will continue with only secondary objectives; primary objective (RCT) terminated.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mount Saint Vincent UniversityUniversity, hospital or other
- Collaborators
- University of Prince Edward Island, Queen's University
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 1 Aug 2019 (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.
Nova Scotia has among the lowest breastfeeding rates in Canada, with less than one quarter of infants receiving Health Canada's recommended 6 months of exclusive breastfeeding. Compared with feeding formula, breastfeeding has been linked with a number of health advantages, including fewer infections, higher IQ, and a lowered risk of obesity later in life.
How infants consume human milk is changing. Pumping milk has grown in popularity in recent years because some mothers may feel stigmatized breastfeeding, especially in public, but also because it allows other caregivers to help with feeding. Although pumped human milk is considered equal to breastfeeding, there is very little research in this area, especially around responsive feeding and later health outcomes. Since pumped milk is fed from a bottle, the health benefits may be lost (for instance, this may impact a baby's ability to understand if s/he is hungry or full).
The primary aim of this study is to determine if the volume of human milk an infant consumes differs if they consume milk from a bottle versus the breast. The investigators will conduct a cross-over trial in which 62 mother-infant pairs will be randomized to feed at the breast or from a bottle for 24 hours, have a 24 hour wash-out period, and then 'cross-over' to another 24 hour session with the opposite 'treatment.' The volume of milk consumed at each feed within the 24 hour window (via indirect weighing, or weighing the baby before and after eating) will be recorded to determine if there are differences in milk consumption. Mother-infant pairs will complete this 3-day study three times, at 6 weeks, 4 months, and 6 months.
Information from this study will help to better understand current infant feeding practices in Nova Scotia, and the potential role this plays in future health outcomes. Evidence from this study may help to identify means of improving feeding practices and promoting human milk as the main food for Nova Scotian infants, setting them on a path for the best start in life.
Detailed description
See attached full protocol document for full details.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a modified, randomized cross-over study. The 'intervention' in this study is simply feeding infants using one of two modalities that are already familiar to the mother and infant: feeding mother's milk from the breast and from a bottle. At each timepoint (6 weeks, 4 months, 6 months) infants will: be randomized using a balanced design (to control for order effect) to consume human milk from a bottle or from the breast for 24 hours; will then undergo a wash-out period in which they will be fed human milk as they usually would for 24 hours; then will complete the second 'treatment' (bottle or breast) for 24 hours. Due to the nature of the intervention, this study will not be blinded. We aim to recruit 62 mother-infant pairs (= 124 participants in total).
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding | Active comparator | Behavioral: (feeding modality)Infant consumes mother's milk directly from the breast. |
| Bottle-feeding | Experimental | Behavioral: (feeding modality)Infant consumes mother's expressed milk from a bottle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| (feeding modality)The intervention is a change in feeding modality: in both arms, infant's will consume mother's milk. The difference in arms is the modality in which human milk is consumed: either directly from the breast, or from a bottle. | Behavioural | Bottle-feeding, Breastfeeding |
Primary outcome
Volume of milk consumption
Time frame: 24 hours
To assess if the volume of human milk consumed by infants differs by feeding modality (bottle feeding human milk versus breastfeeding), assessed as overall milk volume consumed over 24 hours, measured by indirect weighs at each feed during a 24-hour period.
2 secondary outcomes
Infant growth
Time frame: Between 6 weeks and 6 months
Responsive feeding behaviors
Time frame: Between 6 weeks and 6 months
Results and safety
The study was stopped early (reason given: Interim analysis (n=40 24-hr sessions) yielded biologically implausible data. We do not deem this novel, at-home, participant-led method prudent. Study will continue with only secondary objectives; primary objective (RCT) terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Individual participant dataSharing planned: No
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Healthy Volunteers
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.
Kyly C Whitfield, PhD principal investigator
Mount Saint Vincent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (feeding modality) in people with Human Milk and Breastfeeding, run by Mount Saint Vincent University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 19 May 2021. 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 Canada. 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 stopped early (reason given: Interim analysis (n=40 24-hr sessions) yielded biologically implausible data. We do not deem this novel, at-home, participant-led method prudent. Study will continue with only secondary objectives; primary objective (RCT) terminated.). 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?
Volume of milk consumption (time frame: 24 hours). 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 19 May 2021.