Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package: Implementation Research

Preterm Birth Clinical Trial

— LIFT-UP  

Official title:

Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Implementation Research of an In-facility and Community Supportive Care Package in India, Malawi and Tanzania

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390943
• Other study ID #: IRB23-0273
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: Ilana Dzuba, MHS
• Phone: (617) 384-6555
• Email: idzuba[@]ariadnelabs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP) aims to improve feeding and growth outcomes among low birthweight (LBW; <2.5kg) or preterm (<37 weeks gestational age) infants admitted to neonatal intensive care units (NICU) 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 695
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Minute and older

Eligibility

OBJECTIVE 1 (FACILITY-BASED)

Inclusion criteria

Infants

• Low birthweight (=2.5kg) or preterm (<37 weeks) infants admitted to NICU at study facility

• In-born infants admitted to the NICU within 24 hours of birth)

• Mother and infant alive during screening

• Mother consents for herself and infant

• Women (mothers) who are age of majority: Tanzania and India: 18+; Malawi: 16-17 and married OR 18+

Healthcare providers

• Healthcare provider who was trained to deliver the facility-based FSP+

• Healthcare provider consents for him/herself

Exclusion criteria

Infants

• Out-born infants referred to study facility NICU

• Congenital anomalies or acquired conditions that interfere with feeding or placement of nasogastric/ orogastric (NG/OG) tube [e.g., cleft lip/palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, necrotizing enterocolitis]

• Severe birth asphyxia

• Unknown date of birth and unknown gestational age

OBJECTIVE 2 (TRANSITION-TO-HOME)

Inclusion criteria

Infants

• Infants in India-Uttar Pradesh site

• LBW (<2.5kg) or preterm (<37 weeks) infants discharged from a study facility and fulfilling all objective 1 inclusion criteria (exposed to objective 1 intervention)

• Lives within catchment areas of study facility (50km)

• Mother intends to stay in the catchment areas for 3 months post-birth with infant

Community providers

• Community provider who was trained to deliver the transition-to-home FSP+.

• Community provider consents for him/herself

Exclusion criteria

Infants

• Not screened and was not exposed to objective 1 intervention (and meet all eligibility criteria)

• Lives outside the defined catchment area

• Mother does not intend to stay in the catchment areas for 3 months post-birth with infant

Community providers

-Community provider who was not trained to deliver the transition-to-home FSP+.

Related Conditions & MeSH terms

• Birth Weight
• Low Birthweight
• Premature Birth
• Preterm Birth

Intervention

Other:
• Facility-based feeding support package plus (FB-FSP+)
Package of materials to support facility-based feeding and lactation, KMC and WASH, including a training curriculum, training guide, and implementation materials, such as Standard Operating Procedures (SOPs) and job aides
• Transition-to-home feeding support package plus (TTH-FSP+)
Package of materials to support transition-to-home feeding and lactation, KMC and WASH, including a training curriculum, training guide, and implementation materials, such as Standard Operating Procedures (SOPs) and job aides

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Boston Children's Hospital, Brigham and Women's Hospital, Community Empowerment Lab, Emory University, Jawaharlal Nehru Medical College, Muhimbili University of Health and Allied Sciences, PATH, University of North Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Obj 1 & 2: % infants who receive the "minimum package"	The minimum package will be defined and likely be based on milestones that vary by length of stay and perhaps baby status	Obj 1 Pilot: At discharge or at 2 weeks age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation; Obj 2: On day of enrollment and 2 weeks and 6 weeks later
Other	Obj 1: Feeding competency	Pilot only: Mean feeding competency score on on Preterm Infant Breastfeeding Behavior Scale (range 0-20); % of mother-infant dyads who score >15 on Preterm Infant Breastfeeding Behavior Scale; Mature breastfeeding behavior is indicated if the newborn achieves the highest scores on all six items.	Difference between enrollment (within 24 hours of birth) and day of discharge or 2 weeks of age (whichever is first)
Primary	Obj 1: Early initiation of mother's breast milk feeding	% infants initiated breast milk feeding within 1 hour of birth	1 hour after birth
Primary	Obj 1: Early initiation of mother's first breast stimulation	% mothers initiated breast stimulation via first breast milk expression or baby first put to breast within 1 hour of birth	1 hour after birth
Primary	Obj 1: Number of sessions when infant was fed mother's direct or expressed breast milk in previous 24 hours	Mean number of mother's breast milk feeding sessions (direct or expressed) in the last 24 hours	24 hours
Primary	Obj 1: Number of mother's breast milk expression sessions in previous 24 hours	Mean number of sessions in which mother expressed breast milk in the last 24 hours	24 hours
Primary	Obj 1 & 2: Maternal breastfeeding self-efficacy/confidence	Mean score (range 14-70) on validated Breastfeeding Self-Efficacy Scale-Short Form; higher scores reflect more significant levels of breastfeeding self-efficacy	Obj 1 Pilot: On day of facility discharge or at 2 weeks age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation; Obj 2: On day of enrollment and 2 weeks and 6 weeks later
Primary	Obj 2: Growth velocity (g/kg/d)	Mean change in infant's weight (growth) calculated in grams/kilogram/day (g/kg/ day) from facility discharge to study discharge	6 weeks after initial facility discharge
Secondary	Obj 1: Time of first feed of mother's breast milk in NICU	Mean time from NICU admission to first feed of mother's breast milk in NICU	From date/time of enrollment until date/time of first documented feed on mother's breast milk in the NICU, assessed up to facility discharge or 14 days, whichever comes first
Secondary	Obj 1: Growth velocity (g/kg/d)	Mean change in infant's weight (growth) calculated in grams/kilogram/day (g/kg/ day) from birth to facility discharge	Obj 1 Pilot: Birth to day of discharge or 2 weeks of age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation
Secondary	Obj 1: 20g/kg/day weight gain	Obj 1 Pilot: % infants who experienced a change in weight of at least 20g/kg/day between birth and day of discharge or 2 weeks of age; Obj 1 Implementation: % infants who experienced a change in weight of at least 20g/kg/day between birth and day of evaluation (varies by infant)	Obj 1 Pilot: Birth to facility discharge or 2 weeks of age; Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation
Secondary	Obj 1 & 2: Infants fed exclusively on mother's own milk in the previous 24 hours	% infants fed exclusively mother's own milk in the last 24 hours	24 hours
Secondary	Obj 1 & 2: Infants receiving KMC in previous 24 hours	% infants receiving any Kangaroo Mother Care in the last 24 hours	24 hours
Secondary	Obj 1 & 2: Infants receiving at least 8 hours of KMC in last 24 hours	% infants receiving at least 8 hours of Kangaroo Mother Care in last 24 hours	24 hours
Secondary	Obj 1 & 2: Management of feeding difficulties	% of feeding difficulties that mothers reported which were resolved through support	Obj 1 Pilot: Daily referring to the 24 hours assessed from enrollment until facility discharge or 2 weeks of age (whichever occurs first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation
Secondary	Obj 2: Number of sessions when infant was fed mother's direct or expressed breast milk in previous 24 hours	Mean number of mother's breast milk feeding sessions (direct or expressed) in the last 24 hours	24 hours
Secondary	Obj 2: Number of mother's breast milk expression sessions in previous 24 hours	Mean number of sessions in which mother expressed breast milk in the last 24 hours	24 hours