Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390943
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-03-30
Brief Title:
Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package Implementation Research
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFT-UP
Brief 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 25kg 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
Detailed Description:
AIM To improve feeding and growth outcomes among low birthweight LBW 25kg 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 supportmanagement 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 supportmanagement 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 mothersfamilies
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 005 alpha Smaller improvements in key outcomes for the prepost analysis can be detected for the implementation study n80 baseline vs 240 implementation compared to the pilot study n80 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 005 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 feedingexpression 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 leadershipstaff 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 cadres 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 hospitals and communitys 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 15 55 and 105 months after the start of implementation for 15 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 supportmanagement 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 mothers 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 15 months of implementation and another 30 whose babies received care within 55 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 15 months and 55 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
OBJECTIVES
To implement and evaluate a co-designed facility-based lactation supportmanagement 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 supportmanagement 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 mothersfamilies
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 005 alpha Smaller improvements in key outcomes for the prepost analysis can be detected for the implementation study n80 baseline vs 240 implementation compared to the pilot study n80 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 005 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 feedingexpression 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 leadershipstaff 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 cadres 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 hospitals and communitys 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 15 55 and 105 months after the start of implementation for 15 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 supportmanagement 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 mothers 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 15 months of implementation and another 30 whose babies received care within 55 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 15 months and 55 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None