Low-Birth-WeightCKMCNCT02613624
Formative Research to Develop an Intervention Package to Promote Practice of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community (CKMC)
An observational study of Low-Birth-Weight, run by Society for Applied Studies at 1 site in India.
Trial summary
The study is being conducted to develop an intervention to assess the feasibility of implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a community setting. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Low-Birth-Weight
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Rural and semi urban population of two primary health centre areas in two districts of the state of Haryana, India.
Who may be able to join
- Low birth weight or preterm newborns
Who cannot join
- Babies with hospitalization criteria
- unable to feed or weight less than 1500 grams at birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Formative Research to Develop an Intervention Package for Promotion of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community: In Preparation for a Randomized Controlled Trial to Examine Impact of Community Kangaroo Mother Care on Neonatal and Early Infant Mortality
The study is being conducted to develop an intervention to assess the feasibility of implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a community setting. A prototype intervention package will be developed using information obtained from in-depth interviews, focus group discussions and other qualitative research techniques. These interviews will help us identify current behaviours, barriers to adoption of KMC and effective ways to promote KMC in the community. The prototype intervention will be refined by conducting acceptability studies (household trials) with few mothers. The study team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC and following up till KMC is stopped. The process is being documented using observations and interviews. Information is obtained on acceptability of KMC, number of hours per day and number of days KMC was given, breastfeeding practices and support provided by other family members.
- Conditions
- Low-Birth-Weight
- Keywords
- KMC in community
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of community based KMC
To determine whether community KMC is feasible to implement in the study setting and if so, can high enough adoption rates be achieved. This will be ascertained by documenting proportion of mothers doing KMC, number of hours each day and number of days skin to skin contact is given.
Measured: 1 year
Define intervention package
To define an intervention package, including the most effective way(s) to promote KMC in the study setting.
Measured: 1 year
Secondary outcomes (4)
Perceptions and practices of maternal and newborn care
To ascertain perceptions, beliefs and practices around pregnancy, delivery and maternal and newborn care. Qualitative research methods such as focus group discussions, in-depth interviews and observations using open ended questionnaires, interview guides and checklists will be used.
Measured: 1 year
Social norms around birthing practices
To identify social norms around birthing practices for normal, LBW infants and preterms. Qualitative research methods such as focus group discussions, in-depth interviews and observations using open ended questionnaires, interview guides and checklists will be used.
Measured: 1 year
Awareness and perception around KMC
To ascertain awareness and perceptions around KMC. Qualitative research methods such as focus group discussions, in-depth interviews and observations using open ended questionnaires, interview guides and checklists will be used.
Measured: 1 year
Promotion of KMC
To identify ways to promote KMC in the community.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-Birth-WeightStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Centre For International Health
- Responsible party
- Sponsor
- Investigators
- Sarmila Mazumder, MBBS, PhD, Principal investigator, Centre for Health Research and Development, Society for Applied Studies, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613624
- Sponsor's protocol ID
- 2014/1913/REK vest
- Acronym
- CKMC
- Status last verified
- Jan 2016
- First submitted
- 12 Oct 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formative Research to Develop an Intervention Package for Promotion of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community: In Preparation for a Randomized Controlled Trial to Examine Impact of Community Kangaroo Mother Care on Neonatal and Early Infant Mortality
- ClinicalTrials.gov ID
- NCT02613624
- Acronym / sponsor ID
- CKMC / 2014/1913/REK vest
- Conditions
- Low-Birth-Weight
- Keywords
- KMC in community
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- Centre For International Health
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Nov 2015 (estimated)
- 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 study is being conducted to develop an intervention to assess the feasibility of implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a community setting. A prototype intervention package will be developed using information obtained from in-depth interviews, focus group discussions and other qualitative research techniques. These interviews will help us identify current behaviours, barriers to adoption of KMC and effective ways to promote KMC in the community. The prototype intervention will be refined by conducting acceptability studies (household trials) with few mothers. The study team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC and following up till KMC is stopped. The process is being documented using observations and interviews. Information is obtained on acceptability of KMC, number of hours per day and number of days KMC was given, breastfeeding practices and support provided by other family members.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Rural and semi urban population of two primary health centre areas in two districts of the state of Haryana, India.
Key inclusion criteria (1 listed)
- Low birth weight or preterm newborns
Key exclusion criteria (2 listed)
- Babies with hospitalization criteria
- unable to feed or weight less than 1500 grams at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility and acceptability of community based KMC
Time frame: 1 year
To determine whether community KMC is feasible to implement in the study setting and if so, can high enough adoption rates be achieved. This will be ascertained by documenting proportion of mothers doing KMC, number of hours each day and number of days skin to skin contact is given.
Define intervention package
Time frame: 1 year
To define an intervention package, including the most effective way(s) to promote KMC in the study setting.
4 secondary outcomes
Perceptions and practices of maternal and newborn care
Time frame: 1 year
Social norms around birthing practices
Time frame: 1 year
Awareness and perception around KMC
Time frame: 1 year
Promotion of KMC
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
Related trials for Low-Birth-Weight
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension
Not yet recruitingPhase 1
Breast-milk Enema Administration to Stimulate Passage of Meconium
Breast-milk
Recruiting
Relaxation Intervention to Improve Newborn Growth and Maternal Well-being
Well-Being, Psychological, Breastfeeding
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.
Sarmila Mazumder, MBBS, PhD principal investigator
Centre for Health Research and Development, Society for Applied Studies, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-Birth-Weight, run by Society for Applied Studies at 1 site in India.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jan 2016. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility and acceptability of community based KMC (time frame: 1 year). The study lists 2 primary outcomes in all. 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 12 Jan 2016.