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Low Birth WeightCKMC-DEVNCT02631343

Community Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns

A study testing KMC and Essential newborn 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

While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. 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?
KMC and Essential newborn care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
1 siteIndia
Study dates
Nov 2015to May 2017
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

  • Mothers and low birth weight ≥1500gms to ≤2250gms

Who cannot join

  • Birth weight <1500gms
  • Unable to feed on offering feeds, confirmed by study team
  • Infant has breathing problems or less active
  • Mother does not intend to stay in study area for the next 12 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

Official title: A Community-based Model of Delivery of Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns

While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and potentially neurodevelopment, in preterm and low birth weight infants in hospital settings but its coverage remains low. Innovation is required to allow the community-based delivery of KMC by front-line workers. This could greatly accelerate scale up and sustainability of this intervention in low resource settings.

The proposed randomized trial is planned in a setting where 40% of births take place at home. Early discharge (as early as within 12 hours of birth) is common for facility births, often at the request of families for social and cultural reasons. Many of the hospitals do not have incubators for the care of very small babies.

Read the detailed description

Low birth weight (LBW) infants will be identified through surveillance. Eligible infants will be randomized into the intervention and control groups. Mother in the intervention group will be supported by a ANM-like study workers assisted by ASHA-like study workers to provide Kangaroo mother care (KMC) to their babies at home. Breastfeeding support will also be provided to these mothers by ANM-like study workers. Essential newborn care will be delivered through Government workers in both groups. Survival will be measured in all enrolled infants through contacts at 1, 3, 6 and 12 months of age. Information will also be ascertained on initiation of breastfeeding, exclusive breastfeeding rates, incidence of infection in the neonatal and in the 1-5 months period. Development outcomes (Maternal Depression, Maternal sense of competence, Mother-infant Bonding, Mother-infant interaction, Newborn Behaviour, Infant temperament, Brain development) will be measured at enrolment, 6weeks, 6 and 12 months of age. Growth will be measured at enrolment and at 1, 3, 6 and 12 months.

Being tested
KMC, Essential newborn care
Keywords
Kangaroo mother care in the community

What participants receive

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

  • KMCBehavioural

    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

  • Essential newborn careOther

Study groups in NCT02631343
Study groupRoleWhat they receive
Intervention KMCExperimentalPromotion 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: KMC; Other: Essential newborn care
ControlOtherRoutine visits by government health workers
Receives: Other: Essential newborn care

What is being measured

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

  1. Assessment of maternal depression

    The depression will be measured using patient health questionnaire-9

    Measured: 6 weeks

  2. Assessment of maternal depression

    The depression will be measured using patient health questionnaire-9

    Measured: Assessment of maternal depression at 6 months

  3. Assessment of maternal sense of competence

    Maternal sense of competence will be measured by maternal self efficacy questionnaire

    Measured: 6 weeks

  4. Assessment of maternal sense of competence

    Maternal sense of competence will be measured by maternal self efficacy questionnaire

    Measured: Assessment of maternal sense of competence at 12 months

  5. Assessment of mother infant bonding

    Mother infant bonding will be measured by maternal postnatal attachment questionnaire

    Measured: 6 weeks

  6. Assessment of mother infant interaction

    Mother infant interaction will be assessed by video recording and subsequent coding of Joint attention task

    Measured: 6 months

  7. Assessment of newborn behaviour

    Assessment of newborn behaviour by Neonatal behavioural assessment scale

    Measured: 6 weeks

  8. Assessment of infant temperament

    Assessment of infant temperament by infant temperament scale

    Measured: 6 months

  9. Assessment of infant temperament

    Assessment of infant temperament by infant temperament scale

    Measured: Assessment of infant temperament at 12 months

  10. Assessment of cognitive function by Bayley scale

    Measured: 6 months

  11. Assessment of cognitive function by Bayley scale

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

  12. Assessment of home environment by PROCESS

    Measured: 12 months

Secondary outcomes (12)

  1. Neonatal mortality

    Measured: From birth to 28 days

  2. Early infant mortality

    Measured: From birth to 6 months

  3. Early initiation of breastfeeding

    Measured: From birth to 1 month

  4. Proportion exclusively breastfed

    Measured: 1, 3 and 6 months

  5. Weight and length gain

    Measured: 1, 3, 6 and 12 months

  6. Incidence of infection in neonatal

    Measured: 1 month period

  7. Early recognition of illness at 1 month

    Recognition of illness and careseeking will be ascertained from caregivers by using questionnaires

    Measured: 1 month period

  8. Early and appropriate care seeking practices at 1 month

    Early and appropriate care seeking ascertained from caregivers by using questionnaires

    Measured: 1 month period

  9. Early recognition of illness at 3 months

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

  10. Early and appropriate care seeking practices at 3 months

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

  11. Early recognition of illness at 6 months

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

  12. Early and appropriate care seeking practices at 6 months

    Measured: Assessed at 6 months data from 3 months upto 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 posted16 Dec 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionMay 2017
  4. Study completionMay 2017

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
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02631343
Sponsor's protocol ID
0725-03
Acronym
CKMC-DEV
Status last verified
Sep 2018
First submitted
25 Nov 2015
Last updated
7 Sep 2018
Results posted
No
Data monitoring committee
No

Publications

  • Upadhyay RP, Taneja S, Strand TA, Sommerfelt H, Hysing M, Mazumder S, Bhandari N, Martines J, Dua T, Kariger P, Bahl R. Early child stimulation, linear growth and neurodevelopment in low birth weight infants. BMC Pediatr. 2022 Oct 8;22(1):586. doi: 10.1186/s12887-022-03579-6.

    PubMed 36209050

  • Taneja S, Sinha B, Upadhyay RP, Mazumder S, Sommerfelt H, Martines J, Dalpath SK, Gupta R, Kariger P, Bahl R, Bhandari N, Dua T; ciKMC development study group. Community initiated kangaroo mother care and early child development in low birth weight infants in India-a randomized controlled trial. BMC Pediatr. 2020 Apr 4;20(1):150. doi: 10.1186/s12887-020-02046-4.

    PubMed 32247311

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing KMC and Essential newborn 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 1 inclusion and 4 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 Sep 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?

Assessment of maternal depression (time frame: 6 weeks). The study lists 12 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 NCT02631343, which also lists 3 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 Sep 2018.

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