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Low-Birth-WeightKMC-LBWNCT02653534

Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants

A study testing Kangaroo Mother Care in people with Low-Birth-Weight, run by Society for Applied Studies at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. Read more about this study

Who is it for?
Ages Up to 3 daysHealthy volunteers can take part
Conditions the study is for
Low-Birth-Weight
What is being tested?
Kangaroo Mother Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,402 participants
Where
1 siteIndia
Study dates
Nov 2015to Oct 2018
Phase
Interventional
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 3 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Low birth weight babies (≥1500 to ≤2250 g) screened within 3 days and their mothers.
  • Born at home
  • Singleton or twins or triplets
  • Infants born in hospital, discharged and KMC not initiated in the hospital

Who cannot join

  • Infant unable to feed
  • Infant has breathing problem
  • Infant is less active than normal
  • Gross congenital malformations
  • Mother does not intend to stay in the study area for the next 6 months

Trial locations and contacts

1 site in 1 country.

India1 site

  • CHRD, Society for Applied Studies

    Palwal, Haryana, 121102

Other trials in India

About this study

This study is being conducted to assess the impact of promoting community initiated Kangaroo Mother Care (ciKMC) for low birth weight babies on post enrolment neonatal mortality and mortality post enrolment upto 6 months of age. This large individually randomized controlled trial will enroll 10500 low birth weight babies. The secondary objectives are examining the impact of the intervention on exclusive breast feeding and growth at 1 and 3 months, infections and hospitalizations in the neonatal period and from 1 to 5 months of age, recognition of illnesses and early care seeking from appropriate sources, motor and mental development in a subsample.

Newborns weighing >=1500 to <=2250gm are being enrolled into the study within 3 days of birth. Eligible babies are randomized to intervention or control arms. Mothers in the intervention arm are supported for KMC and breastfeeding by study ANM (Auxiliary Nurse Midwife) and study ASHA (Accredited Social Health Activist) like workers . Routine home visits are conducted in both intervention and control arms by government workers according to the existing government program.

Read more

Survival will be ascertained in all enrolled infants through contacts at 1, 3 and 6 months.

The data safety and monitoring committee (DSMC) conducted two interim analyses, first in September 2017 when about half of the infants had been enrolled, and second in June 2018, when almost three quarters of the enrolled babies had been followed till 28 days of age. Following the second interim analysis, the DSMC concluded that a sufficient number of infants would be enrolled by the end to September 2018 to clearly answer the study question concerning the impact of ciKMC on both neonatal and early infant mortality. The DSMC recommended that data collection be completed by the end of October 2018.

Being tested
Kangaroo Mother Care
Keywords
Kangaroo Mother Care in community, mortality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kangaroo Mother CareBehavioural

    Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers

Study groups in NCT02653534
Study groupRoleWhat they receive
Intervention Kangaroo Mother CareExperimentalPromotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers
Receives: Behavioral: Kangaroo Mother Care
ControlNo interventionRoutine visits by government health workers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal mortality from post enrolment to 28 days

    Measured: From post enrolment to 28 days

  2. Early infant mortality from post enrolment to 6 months of age

    Measured: From post enrolment to 6 months

Secondary outcomes (13)

  1. Proportion exclusively breastfed at 1 and 3 months

    Measured: 1 month, 3 months

  2. Weight gain

    Measured: 1, 3 and 6 months

  3. Length gain

    Measured: 1, 3 and 6 months

  4. Incidence of infection and hospitalization

    Measured: 1 month and 1 to 5 months

  5. Early recognition of illness at 1 month

    Recognition of illness will be ascertained from caregivers by using questionnaire

    Measured: 1 month period

  6. Early appropriate care seeking practices at 1 month

    Early appropriate care seeking ascertained from caregivers by using questionnaire

    Measured: 1 month period

  7. Early recognition of illness at 3 months

    Recognition of illness ascertained from caregivers by using questionnaire

    Measured: Assessed at 3 months, data from 1 month upto 3 months

  8. Early appropriate care seeking practices at 3 months

    Early appropriate care-seeking ascertained from caregivers by using questionnaire

    Measured: Assessed at 3 months, data from 1 month upto 3 months

  9. Early recognition of illness at 6 months

    Recognition of illness ascertained from caregivers by using questionnaire

    Measured: Assessed at 6 months, data from 3 months upto 6 months

  10. Early appropriate care seeking practices at 6 months

    Early appropriate care-seeking practices ascertained by using questionnaire

    Measured: Assessed at 6 months, data from 3 months upto 6 months

  11. Assessment of cognitive function by Bayley scale in a subsample

    Measured: Assessment of cognitive function by Bayley scale at 6 months

  12. Assessment of cognitive function by Bayley scale in a subsample

    Measured: Assessment of cognitive function by Bayley scale at 12 months

  13. Head circumference

    Measured: 1, 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionOct 2018
  4. Study completionOct 2018

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8,402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653534
Sponsor's protocol ID
2015/1486/REK vest
Acronym
KMC-LBW
Status last verified
Dec 2015
First submitted
26 Dec 2015
Last updated
7 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Choudhary TS, Kumar M, Sinha B, Shaikh S, Mazumder S, Taneja S, Bhandari N. Anthropometric Indicators as Predictors of Mortality in Early Life Among Low Birthweight Indian Infants. Front Nutr. 2022 Jul 12;9:884207. doi: 10.3389/fnut.2022.884207. eCollection 2022.

    PubMed 35903458

  • Sinha B, Choudhary TS, Nitika N, Kumar M, Mazumder S, Taneja S, Bhandari N. Linear Growth Trajectories, Catch-up Growth, and Its Predictors Among North Indian Small-for-Gestational Age Low Birthweight Infants: A Secondary Data Analysis. Front Nutr. 2022 May 24;9:827589. doi: 10.3389/fnut.2022.827589. eCollection 2022.

    PubMed 35685868

  • Choudhary TS, Mazumder S, Haaland OA, Taneja S, Bahl R, Martines J, Bhan MK, Johansson KA, Sommerfelt H, Bhandari N, Norheim OF. Health equity impact of community-initiated kangaroo mother care: a randomized controlled trial. Int J Equity Health. 2021 Dec 24;20(1):263. doi: 10.1186/s12939-021-01605-0.

    PubMed 34952592

  • Mazumder S, Taneja S, Dube B, Bhatia K, Ghosh R, Shekhar M, Sinha B, Bahl R, Martines J, Bhan MK, Sommerfelt H, Bhandari N. Effect of community-initiated kangaroo mother care on survival of infants with low birthweight: a randomised controlled trial. Lancet. 2019 Nov 9;394(10210):1724-1736. doi: 10.1016/S0140-6736(19)32223-8. Epub 2019 Oct 4.

    PubMed 31590989

  • Mazumder S, Taneja S, Dalpath SK, Gupta R, Dube B, Sinha B, Bhatia K, Yoshida S, Norheim OF, Bahl R, Sommerfelt H, Bhandari N, Martines J. Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial. Trials. 2017 Jun 7;18(1):262. doi: 10.1186/s13063-017-1991-7.

    PubMed 28592313

Questions about this trial

What is this clinical trial studying?

A study testing Kangaroo Mother Care in people with 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 4 inclusion and 5 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 7 Dec 2018. 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?

Neonatal mortality from post enrolment to 28 days (time frame: From post enrolment to 28 days). 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?

On the ClinicalTrials.gov record for NCT02653534, which also lists 5 linked publications.

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 7 Dec 2018.

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