LBWPhase 2KMCNCT01776281
Effects of Kangaroo Mother Care Among Low Birth Weight (LBW) and Preterm Infants
A Phase 2 study testing Kangaroo Mother Care in people with LBW and Preterm, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of deaths among premature and low birth weight LBW infants. Even if the infants are born in facilities, incidences of cold stress are possible due to insufficient resources, space and incompetent practices to manage hypothermia in… Read more about this study
- Who is it for?
- Ages 1 day to 1 week
- What is being tested?
- Kangaroo Mother Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2012to Aug 2012
- Phase
- Phase 2
- 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 1 day to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any preterm neonates (< 37 weeks of gestation by maternal dates)
- Low birth weight infants less than 2500 gm.
Who cannot join
- Infants with brain hemorrhage, congenital abnormalities.
- Infants needed double phototherapy.
- Mothers with severe depression, sickness with intensive care requirements. Mother who refused to participate. Mothers who delivered live multiple babies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Kangaroo Mother Care Among LBW and Preterm Infants:A Randomized Control Trial in Karachi
- Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of deaths among premature and low birth weight LBW infants. Even if the infants are born in facilities, incidences of cold stress are possible due to insufficient resources, space and incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo Mother Care is a well-known intervention to address the issues related to preterm births, such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC interventions for preterm infants, no interventional study has been found in literature in Pakistani context. Looking at the potential benefits of KMC in reducing the related complications of prematurity, the study aims to identify the effectiveness of KMC among preterm and LBW infants born in secondary hospital of Aga khan University hospitals.
Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and LBW infants as compared to the usual care.
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Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome among experimental and control group.
Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of suspected infections during hospitalization.
Hypothesis II Ha: There is a difference in length of stay among experimental group and control group.
Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four weeks.
Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and control after discharge from hospital.
- Being tested
- Kangaroo Mother Care, Standard Care
- Keywords
- effects, KMC, LBW, preterm, temperature, breastfeeding, secondary hospitals
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother CareBehavioural
Standard CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Mother Care | Experimental | Other than routine clinical care per hospital policy. Infants will receive skin-to-skin contact for minimum one hour daily during hospital stay and at home till one month. Receives: Behavioral: Kangaroo Mother Care |
| Standard Care | Active comparator | Routine incubator or cot care with breastfeeding support from nurses as per policy. Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding outcomes
Comparison of breastfeeding frequency per day, method of feeding. (partial/ exclusive)in hospital and at home.
Breastfeeding behaviour by using preterm Infants breastfeeding behaviour Scale(PIBBS).
Follow-up till one months by calling and record keeping of breastfeeding status.
Measured: 30 days
Secondary outcomes (3)
Rate of Infection
frequency of presume sepsis and need for antibiotics.
Measured: 1-2 weeks(During hospital stay)
length of stay
Total days in hospital during the recruitment period.
Measured: 1-2 weeks
weight gain
After discharge observation for weight gain in Follow-up visit.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LBWStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ms Seema Hyderali, Aga Khan University
- Investigators
- Rozina Karmaliani, PhD, Study director, Aga Kahn University School of Nursing and MidwiferyZulfiqar Bhutta, Study director, AKUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776281
- Sponsor's protocol ID
- SHyderali
- Acronym
- KMC
- Status last verified
- Jan 2013
- First submitted
- 22 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kangaroo Mother Care Among LBW and Preterm Infants:A Randomized Control Trial in Karachi
- ClinicalTrials.gov ID
- NCT01776281
- Acronym / sponsor ID
- KMC / SHyderali
- Keywords
- effects, KMC, LBW, preterm, temperature, breastfeeding, secondary hospitals
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Jan 2013 (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.
- Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of deaths among premature and low birth weight LBW infants. Even if the infants are born in facilities, incidences of cold stress are possible due to insufficient resources, space and incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo Mother Care is a well-known intervention to address the issues related to preterm births, such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC interventions for preterm infants, no interventional study has been found in literature in Pakistani context. Looking at the potential benefits of KMC in reducing the related complications of prematurity, the study aims to identify the effectiveness of KMC among preterm and LBW infants born in secondary hospital of Aga khan University hospitals.
Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and LBW infants as compared to the usual care.
Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome among experimental and control group.
Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of suspected infections during hospitalization.
Hypothesis II Ha: There is a difference in length of stay among experimental group and control group.
Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four weeks.
Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and control after discharge from hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Mother Care | Experimental | Behavioral: Kangaroo Mother CareOther than routine clinical care per hospital policy. Infants will receive skin-to-skin contact for minimum one hour daily during hospital stay and at home till one month. |
| Standard Care | Active comparator | Behavioral: Standard CareRoutine incubator or cot care with breastfeeding support from nurses as per policy. |
Who may qualify
- Ages
- 1 day to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Any preterm neonates (< 37 weeks of gestation by maternal dates)
- Low birth weight infants less than 2500 gm.
Key exclusion criteria (3 listed)
- Infants with brain hemorrhage, congenital abnormalities.
- Infants needed double phototherapy.
- Mothers with severe depression, sickness with intensive care requirements. Mother who refused to participate. Mothers who delivered live multiple babies.
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 |
|---|---|---|
| Kangaroo Mother Care | Behavioural | Kangaroo Mother Care |
| Standard Care | Behavioural | Standard Care |
Primary outcome
Breastfeeding outcomes
Time frame: 30 days
Comparison of breastfeeding frequency per day, method of feeding. (partial/ exclusive)in hospital and at home. Breastfeeding behaviour by using preterm Infants breastfeeding behaviour Scale(PIBBS). Follow-up till one months by calling and record keeping of breastfeeding status.
3 secondary outcomes
Rate of Infection
Time frame: 1-2 weeks(During hospital stay)
length of stay
Time frame: 1-2 weeks
weight gain
Time frame: 30 days
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 28 Jan 2013.
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.
Rozina Karmaliani, PhD study director
Aga Kahn University School of Nursing and Midwifery
Zulfiqar Bhutta study director
AKUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kangaroo Mother Care in people with LBW and Preterm, run by Aga Khan University at 1 site in Pakistan.
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 2 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: finished, as of the sponsor's last update on 28 Jan 2013. 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 Pakistan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Breastfeeding outcomes (time frame: 30 days). 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 28 Jan 2013.