Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India

University of Massachusetts, Worcester

Status: Active, not recruiting

Conditions: Kangaroo Care; Skin to Skin Contact; Low Birth Weight; Preterm Birth

Treatments: Behavioral: Behavioral Interventions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07231432

K23HD112602-01A1 (U.S. NIH Grant/Contract)

K23HD112602 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 190 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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190 participants in 8 patient groups

Base Intervention + Behavioral Interventions A + B + C

Experimental group

Treatment:

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Interventions A + B

Experimental group

Treatment:

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Interventions A + C

Experimental group

Treatment:

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Intervention A

Experimental group

Treatment:

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Interventions B + C

Experimental group

Treatment:

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Intervention B

Experimental group

Treatment:

Behavioral: Behavioral Interventions

Base Intervention + Behavioral Intervention C

Experimental group

Treatment:

Behavioral: Behavioral Interventions

Base Intervention + No Experimental Behavioral Interventions

No Intervention group