AIM: To improve feeding and growth outcomes among low birthweight (LBW; <2.5kg) or
preterm (<37 weeks gestational age) infants admitted to NICUs in India, Malawi, and
Tanzania by (1) supporting the initiation, establishment, and maintenance of maternal
lactation and prioritized provision of human milk, Kangaroo Mother Care (KMC) and
appropriate water, sanitation and hygiene (WASH) practices; and (2) facilitating feeding
counseling at home post-discharge from the facility.
OBJECTIVES:
To implement and evaluate a co-designed facility-based lactation support/management and
feeding counseling + KMC + WASH package (FB-FSP+: Facility-Based Feeding Support Package
Plus) for LBW or preterm infants admitted to the neonatal intensive care unit (NICU) and
their families from birth to discharge.
To implement and evaluate a co-designed, scalable transition-to-home lactation
support/management and feeding counseling + KMC + WASH package (TTH-FSP+: Transition to
Home Feeding Support Package Plus) for LBW or preterm infants discharged home from the
NICU in India and their mothers/families.
STUDY DESIGN: This multi-site, mixed-methods adaptive implementation science research
study will collect quantitative and qualitative data to evaluate the training of
providers, the impact of each intervention on key infant feeding, growth, and other
health outcomes, the feasibility and acceptability of each intervention for mothers and
providers, and the overall experience of mother-infant dyads. Investigators will apply
the RE-AIM framework to unpack Reach, Effectiveness, Adoption, Implementation, and
Maintenance. Findings will lead to recommendations for iteration and scale-up of the FB-
and TTH-FSP+. Investigators will evaluate multiple primary and secondary quantitative
outcomes to assess effectiveness.
SAMPLE SIZE: Overall, investigators will enroll 695 participants, 50% in India, 50% in
Malawi & Tanzania: up to 520 infants (463 mothers assuming 11% twin rate), 110 mothers
(in-depth interviews), 30 healthcare providers, 15 study staff, and 20 community
providers.
Objective 1: A sample of 80 infants and their mothers is sufficient to detect the effect
sizes for each of the primary and secondary outcomes with 80% power, 0.05 alpha. Smaller
improvements in key outcomes for the pre/post analysis can be detected for the
implementation study (n=80 baseline vs 240 implementation) compared to the pilot study
(n=80 baseline vs 80 pilot).
Objective 2: Investigators will conduct up to 40 in-depth interviews (IDIs) with
providers and 20 with mothers. A sample of 60 infants and their mothers is sufficient to
detect the effect sizes for each of the primary and secondary outcomes with 80% power,
0.05 alpha.
ENROLLMENT: OBJECTIVE 1 (FB-FSP+) Mother-infant dyads (quantitative): All infants born in
a study facility will receive immediate maternal and newborn care per World Health
Organization recommendations, including breast milk feeding/expression support within 1
hour. Inborn LBW or preterm infants admitted to the NICU will be screened for eligibility
and their mothers consented.
Mothers (qualitative): Mothers will be recruited and consented before discharge from
study facilities.
Research Nurses (qualitative): Research nurses providing the intervention will be
consented prior to IDIs.
Healthcare providers (quantitative): Appropriate labor ward, NICU, and step-down ward
providers will be identified by facility and NICU leadership/staff to implement the
FB-FSP+ and consented.
Healthcare providers (qualitative): NICU providers will be recruited and consented during
study implementation.
ENROLLMENT FOR OBJECTIVE 2 (TTH-FSP+, INDIA ONLY) Mothers (quantitative): Mothers exposed
to Objective 1 will be recruited around the time of discharge and consented.
Community providers (quantitative): Community providers within a given cadre(s) who
provide care to LBW or preterm infants within the catchment area will be recruited and
consented.
Mothers (qualitative): Mothers receiving the TTH-FSP+ will be recruited and consented
during study visits.
Community providers (qualitative): Community providers will be recruited and consented
after beginning implementation of the TTH-FSP+.
STUDY INTERVENTION: The FB-FSP+ and the TTH-FSP+ will build on an existing Specialized
Lactation Support and Newborn Nutrition for the Small and Sick Newborn Training
curriculum to include support for KMC and WASH. The FSP+ will include a training guide,
Standard Operating Procedures and job aids specific to each hospital's and community's
needs identified through co-design workshops with key stakeholders that utilize
human-centered design methods.
DATA COLLECTION FOR OBJECTIVE 1 (FB-FSP+) Data will be collected in 3 phases.
Baseline data collection will occur over 6 weeks among eligible mother-infant dyads prior
to introducing the intervention. Baseline will be the comparison group for the
implementation research study and the pilot study.
A 6-week pilot study conducted by research staff in each country will assess the
acceptability, feasibility, and impact of the ideal delivery of the FB-FSP+. A quick
final iteration of the FSP+ will occur before implementing in phase 3.
The FB-FSP+ will be implemented for 1 year using an adaptive models-based approach. Three
consecutive models will be implemented for 4 months each. Investigators will collect
panel data at 1.5, 5.5, and 10.5 months after the start of implementation for 1.5 months
to assess effectiveness and inform model adaptations. Different mother-infant dyads will
be surveyed at each time point to assess differences in the impact of implementation over
time.
Prior to start, healthcare providers will be selected and trained to implement the FSP+
as part of their regular workload. They will complete a knowledge, attitudes, and
practices (KAP) survey on lactation support/management, feeding, KMC, and WASH (1) prior
to training, (2) immediately post-training, and (3) 6 months post-training.
Data collection with mother-infant dyads will take 1-2 hours at one time point between
NICU admission and day of discharge during panel data collection. Mothers will be asked
about their demographics, pregnancy history, health, and their infants' health. Study
staff will take the mother's weight and height, the infants' weight, length, head
circumference and mid-upper arm circumference (MUAC), and data from mothers' and infants'
charts.
A subset of 60 mothers exposed to the FB-FSP+ will be interviewed by study staff, 30 of
whom whose babies received care in the NICU within 1.5 months of implementation and
another 30 whose babies received care within 5.5 months. Interviews will explore mothers'
experiences and perceptions of the acceptability and feasibility of the FB-FSP+.
A subset of 15-30 healthcare providers across all sites will be interviewed per time
point at 1.5 months and 5.5 months after implementing the FB-FSP+. Investigators aim to
interview the same providers at both times to understand how implementation has affected
their practices, skills and workload over time. Interviews will explore acceptability and
feasibility of the FB-FSP+ and barriers and facilitators to its implementation.
DATA COLLECTION FOR OBJECTIVE 2 (TTH-FSP+, INDIA ONLY) Baseline data collection will
occur before implementing the TTH-FSP+ among mothers exposed to the FB-FSP+ and
discharged home. Data collection points will be on the day of discharge and at 2 and 6
weeks post-discharge.
The TTH-FSP+ will be implemented for 6 months, using an adaptive models-based approach.
Three models will be consecutively implemented for 3 months each. Quantitative and
qualitative analysis will begin after 2 months to inform model adaptations. Data
collection points will be on the day of discharge and at 2 and 6 weeks post-discharge.
Community providers will be trained to deliver the TTH-FSP+ for dyads residing in a
defined catchment area once they are discharged home. Community providers will complete a
KAP survey on feeding counseling, KMC, and WASH at three timepoints: (1) just prior to
training, (2) immediately post-training, and (3) 6 months post-training.
Data collection will begin on the day of discharge prior to leaving the facility, and
mothers will respond to questions about their demographics, pregnancy history, health,
and their infants' health. During 2 home visits, mothers will respond to questions on
breastfeeding self-efficacy and health, as well as their infants' health and feeding
practices. Mothers' weight and height will be measured at one study visit. The infants'
weight, length, head circumference and MUAC will be measured at each study visit.
Interviews with mothers will be done at 6 weeks post-discharge during implementation of
Model 1 & 2 and will explore their experiences with the TTH-FSP+ and their perspectives
on its acceptability and feasibility .
Interviews with community providers will be conducted once during implementation of each
Model 1 & 2. Investigators aim to interview the same providers at both time points.
Interviews will explore community providers' experiences delivering the TTH-FSP+ and
their perspectives on its acceptability and feasibility.