Responsive Feeding of Infants With Expressed Milk (REFINE)

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).

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.

Study Overview

• Status: Terminated
• Conditions: Feeding Behavior; Breastfeeding; Human Milk
• Intervention / Treatment: Behavioral: (feeding modality)

Detailed Description

See attached full protocol document for full details.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3M2J6
      • MAMA Lab, Mount Saint Vincent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breastfeeding; Infant consumes mother's milk directly from the breast.	Behavioral: (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.
Experimental: Bottle-feeding; Infant consumes mother's expressed milk from a bottle.	Behavioral: (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Between 6 weeks and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding environment	To gain a better understanding of current infant feeding practices, including responsive feeding, among caregivers in the Halifax Regional Municipality, contextualize why women are pumping, and gain insight around how human milk is handled, stored, and prepared through open-ended one-on-one interviews with mothers.	Between 6 weeks and 6 months

Collaborators and Investigators

• Sponsor: Mount Saint Vincent University
• Collaborators: Queen's University; University of Prince Edward Island

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: responsive feeding; expressing/pumping human milk
• Other Study ID Numbers: MSVUREB2018-155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No