Kangaroo Care, Low Birth Weight, Preterm Birth, Skin to Skin Contact
Conditions
Brief summary
The goal of this study is to develop ways to help mothers of preterm or low birth weight infants do Kangaroo Care at home after discharge from the Neonatal Intensive Care Unit in rural India.
Detailed description
This study aims to create and evaluate interventions to support the practice of Kangaroo Care among mothers of preterm or low birth weight infants in the community-seeing after discharge from the Neonatal Intensive Care Unity. Using a mixed methods and Multiphase Optimization Strategy (MOST) design-based trial, we aim to: Aim 1: Use community-engaged research and qualitative methods to refine up to four individual candidate interventions to overcome barriers to community-based Kangaroo Care, Aim 2: Pilot individual candidate interventions to assess implementation outcomes and define optimization criterion tailored for the community setting, Aim 3: Conduct a MOST design-based optimization trial to develop a community-informed, multicomponent intervention to promote community-based Kangaroo Care
Interventions
BEHAVIORALBehavioral Interventions
The interventions have not been determined yet. The intervention aspect of the study is not active at this time. This information will be updated at a later time to include more details.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Aim 1 consists of focus groups and qualitative analysis. Aim 2 consists of pilot testing interventions. Aim 3 includes the interventional study model, which is described here. As a part of the Multiphase Optimization Strategy (MOST) design-based trial, Aim 3 consists of an optimization trial using full factorial design to test combinations of intervention components, known as experimental conditions, and identify key combinations to include in an optimized, multicomponent intervention.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
AIM 1 Mothers * Mothers of former low birthweight (\<2500 grams at birth) infants who were hospitalized in the Shree Krishna Hospital NICU * Performed Kangaroo Care during their infant's hospitalization * Live in a village that is adopted by and within a 50-kilometer radius of Shree Krishna Hospital * At least 18 years old * Speak Gujarati Healthcare Providers- Physicians: * Physicians and nurses who work in either the Shree Krishna Hospital NICU or in community settings within a 50-kilometer radius who provide newborn care to at least 3 newborns each week * At least 18 years old * Speak Gujarati Village Health Workers: * Village health workers who operate in one of the adopted villages within a 50-kilometer radius of Shree Krishna Hospital * We will aim to recruit one health worker from 10 of the 15 subregions of the district of Anand, based on geography * At least 18 years old * Speak Gujarati AIM 2 Mothers: * Mothers of an infant born with low birthweight (\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g * Must reside in a village adopted by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge * Speaks Gujarati * At least 18 years old AIM 3 Mothers: * Mothers of an infant born with low birthweight (\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g * Must reside in a village adopted by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge * Speaks Gujarati * At least 18 years old
Exclusion criteria
(applicable to all aims) * Persons unable to provide informed consent * Pregnant women may enroll in this study, though, we will not be intentionally recruiting pregnant women. (Refer to section 18 for more information on this) * Prisoners will not be included in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of community-based Kangaroo Care use | 6 weeks | Self-report of any Kangaroo Care at home after NICU discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Self-Efficacy to perform Kangaroo Care | 6 weeks | Maternal Self-Efficacy Scale questionnaire |
| Adherence to community-based Kangaroo Care | 6 weeks | Self-report of the last date Kangaroo Care was performed at home |
| Frequency of community-based Kangaroo Care use | 6 weeks | Self-report of number of days Kangaroo Care was provided at home |
| Acceptability of the intervention | 6 weeks | Client Satisfaction Questionnaire |
| Maternal Intention to perform Kangaroo Care | Baseline (day 0) | Self-report of intention to perform Kangaroo Care at home |
| Material Costs of the intervention | 6 weeks | Cumulative cost of intervention delivery per participant |
| Engagement with the intervention | 6 weeks | Self-reported engagement with intervention (# of instances) |
| Feasibility of the intervention | 6 weeks | Feasibility of Intervention Measure questionnaire |
| Usability of the intervention | 6 weeks | System Usability Scale questionnaire |
| Appropriateness of the intervention | 6 weeks | Qualitative Exit Interview with a trained member of the research staff |
Countries
United States
Outcome results
None listed