Preterm BirthNCT07231432
Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India
A study testing Behavioral Interventions in people with Preterm Birth and Skin to Skin Contact, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Skin to Skin Contact, Low Birth Weight
- What is being tested?
- Behavioral Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Promoting Community-based Kangaroo Care Among Mothers of Low Birth Weight Infants in Rural India
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.
Read the 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
- Conditions
- Preterm Birth, Skin to Skin Contact, Low Birth Weight, Kangaroo Care
- Being tested
- Behavioral Interventions
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Base Intervention + Behavioral Interventions A + B + C | Experimental | Not described Receives: Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Interventions A + B | Experimental | Not described Receives: Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Interventions A + C | Experimental | Not described Receives: Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Intervention A | Experimental | Not described Receives: Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Interventions B + C | Experimental | Not described Receives: Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Intervention B | Experimental | Not described Receives: Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Intervention C | Experimental | Not described Receives: Behavioral: Behavioral Interventions |
| Base Intervention + No Experimental Behavioral Interventions | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of community-based Kangaroo Care use
Self-report of any Kangaroo Care at home after NICU discharge
Measured: 6 weeks
Secondary outcomes (10)
Maternal Intention to perform Kangaroo Care
Self-report of intention to perform Kangaroo Care at home
Measured: Baseline (day 0)
Maternal Self-Efficacy to perform Kangaroo Care
Maternal Self-Efficacy Scale questionnaire
Measured: 6 weeks
Adherence to community-based Kangaroo Care
Self-report of the last date Kangaroo Care was performed at home
Measured: 6 weeks
Frequency of community-based Kangaroo Care use
Self-report of number of days Kangaroo Care was provided at home
Measured: 6 weeks
Acceptability of the intervention
Client Satisfaction Questionnaire
Measured: 6 weeks
Appropriateness of the intervention
Qualitative Exit Interview with a trained member of the research staff
Measured: 6 weeks
Material Costs of the intervention
Cumulative cost of intervention delivery per participant
Measured: 6 weeks
Engagement with the intervention
Self-reported engagement with intervention (# of instances)
Measured: 6 weeks
Feasibility of the intervention
Feasibility of Intervention Measure questionnaire
Measured: 6 weeks
Usability of the intervention
System Usability Scale questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start18 Jun 2025
- Primary completion13 Aug 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nisha Fahey, University of Massachusetts, Worcester
- Investigators
- Nisha Fahey, DO, MSc, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231432
- Sponsor's protocol ID
- K23HD112602
- Other IDs
- K23HD112602-01A1
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sufficient data from this project will be preserved to validate and replicate research findings described in the Aims. The final dataset will include self-reported demographics, behavioral beliefs, acceptability, appropriateness, material costs, engagement, feasibility, usability, uptake, frequency, and adherence. Additional data sets will include coded qualitative data. We will share de-identified individual participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Community-based Kangaroo Care Among Mothers of Low Birth Weight Infants in Rural India
- ClinicalTrials.gov ID
- NCT07231432
- Acronym / sponsor ID
- K23HD112602
- Conditions
- Preterm Birth, Skin to Skin Contact, Low Birth Weight, Kangaroo Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 13 Aug 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
- 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.
| Arm | Type | Receives |
|---|---|---|
| Base Intervention + Behavioral Interventions A + B + C | Experimental | Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Interventions A + B | Experimental | Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Interventions A + C | Experimental | Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Intervention A | Experimental | Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Interventions B + C | Experimental | Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Intervention B | Experimental | Behavioral: Behavioral Interventions |
| Base Intervention + Behavioral Intervention C | Experimental | Behavioral: Behavioral Interventions |
| Base Intervention + No Experimental Behavioral Interventions | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionsThe 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. | Behavioural | Base Intervention + Behavioral Intervention A, Base Intervention + Behavioral Intervention B, Base Intervention + Behavioral Intervention C, Base Intervention + Behavioral Interventions A + B, Base Intervention + Behavioral Interventions A + B + C, Base Intervention + Behavioral Interventions A + C, Base Intervention + Behavioral Interventions B + C |
Primary outcome
Uptake of community-based Kangaroo Care use
Time frame: 6 weeks
Self-report of any Kangaroo Care at home after NICU discharge
10 secondary outcomes
Maternal Intention to perform Kangaroo Care
Time frame: Baseline (day 0)
Maternal Self-Efficacy to perform Kangaroo Care
Time frame: 6 weeks
Adherence to community-based Kangaroo Care
Time frame: 6 weeks
Frequency of community-based Kangaroo Care use
Time frame: 6 weeks
Acceptability of the intervention
Time frame: 6 weeks
Appropriateness of the intervention
Time frame: 6 weeks
Material Costs of the intervention
Time frame: 6 weeks
Engagement with the intervention
Time frame: 6 weeks
Feasibility of the intervention
Time frame: 6 weeks
Usability of the intervention
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Yes. Sufficient data from this project will be preserved to validate and replicate research findings described in the Aims. The final dataset will include self-reported demographics, behavioral beliefs, acceptability, appropriateness, material costs, engagement, feasibility, usability, uptake, frequency, and adherence. Additional data sets will include coded qualitative data. We will share de-identified individual participant-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisha Fahey, DO, MSc principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Interventions in people with Preterm Birth and Skin to Skin Contact, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of community-based Kangaroo Care use (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.