Low Birth WeightEtudeTKNCT00531492
Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries
A study testing TK as soon as possible within 24 hours after birth and Conventional care in people with Low Birth Weight, run by Foundation for Advanced Studies on International Development at 1 site in Madagascar.
Trial summary
The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Low Birth Weight
- What is being tested?
- TK as soon as possible within 24 hours after birth and Conventional care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteMadagascar
- Study dates
- Aug 2007to Mar 2009
- 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 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight (BW) < 2500g
- Delivery at maternity of CHUM (Birth < 24 hours)
- Without serious congenital malformation
- Sat O2 >=95％, HR > 100 / min, RR < 60 / min, Capillary refilling time < 3 sec
- The mother and the family are motivated to practice TK.
- The mother and the family available to practise TK should be healthy.
Who cannot join
- Apnea of prematurity >20 sec
- With intravenous infusion
Trial locations and contacts
1 site in 1 country.
Madagascar1 site
University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),
Mahajanga, Mahajanga
About this study
Official title: Randomized Controlled Trial of Continuous Skin to Skin Care (Technique Kangourou: TK) for Low Birth Weight (LBW) Infants and Their Mothers at University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar
The purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country.
For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.
- Conditions
- Low Birth Weight
- Being tested
- TK as soon as possible within 24 hours after birth, Conventional care
- Keywords
- Maternal and child health, Developing country, Skin to skin care, Newly born low birth weight infants and their mothers, (Delivery at University Hospital Center, Mahajanga, Madagascar)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TK as soon as possible within 24 hours after birthBehavioural
Start TK as soon as possible within 24 hours after birth
Conventional careOther
Start conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Behavioral: TK as soon as possible within 24 hours after birth |
| B | Active comparator | Not described Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality within 28 days after birth
Measured: within 28 days after birth
Secondary outcomes (15)
Mobility within 28 days after birth
Measured: within 28 days after birth
Mortality and Mobility within 28 days after birth
Measured: within 28 days after birth
Difference of (Baby's) loss in weight within 2 days
Measured: within 2 days
Difference of (Baby's) Body weight of 14th day after birth
Measured: 14th day after birth
Difference of (Baby's) Body weight of 28th day after birth
Measured: 28th day after birth
Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）
Measured: Within 28 days after birth
Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)
Measured: within 28 days after birth
Incidence of apnea during hospitalisation (> 20 sec)
Measured: within 28 days after birth
Incidence of desaturation during hospitalisation ( <87%)
Measured: within 28 days after birth
Length of hospitalisation
Measured: within 28 days after birth
Discharge within 7days after birth
Measured: within 7days after birth
Mobility within 6 months or 1 year after birth
Measured: within 6 months or 1 year
Mortality and Morbility within 6 months or 1 year after birth
Measured: within 6 months or 1 year
Mortality within 6 months or 1 year after birth
Measured: within 6 months or 1 year
Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）
Measured: Within 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Advanced Studies on International Development
- Sponsor type
- University, hospital or other
- Collaborators
- St.Luke's Life Science Institute, Tokyo, Japan
- Responsible party
- Principal investigator, Shuko Nagai, Foundation for Advanced Studies on International Development
- Investigators
- Shuko Nagai, MD, Principal investigator, Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531492
- Sponsor's protocol ID
- FASID-06-CE-56
- Acronym
- EtudeTK
- Status last verified
- Dec 2011
- First submitted
- 17 Sep 2007
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nagai S, Andrianarimanana D, Rabesandratana N, Yonemoto N, Nakayama T, Mori R. Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trial. Acta Paediatr. 2010 Jun;99(6):827-35. doi: 10.1111/j.1651-2227.2009.01676.x. Epub 2010 Jan 27.
PubMed 20121708Nagai S, Yonemoto N, Rabesandratana N, Andrianarimanana D, Nakayama T, Mori R. Long-term effects of earlier initiated continuous Kangaroo Mother Care (KMC) for low-birth-weight (LBW) infants in Madagascar. Acta Paediatr. 2011 Dec;100(12):e241-7. doi: 10.1111/j.1651-2227.2011.02372.x. Epub 2011 Jun 23.
PubMed 21635363
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Continuous Skin to Skin Care (Technique Kangourou: TK) for Low Birth Weight (LBW) Infants and Their Mothers at University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM), Madagascar
- ClinicalTrials.gov ID
- NCT00531492
- Acronym / sponsor ID
- EtudeTK / FASID-06-CE-56
- Conditions
- Low Birth Weight
- Keywords
- Maternal and child health, Developing country, Skin to skin care, Newly born low birth weight infants and their mothers, (Delivery at University Hospital Center, Mahajanga, Madagascar)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Foundation for Advanced Studies on International DevelopmentUniversity, hospital or other
- Collaborators
- St.Luke's Life Science Institute, Tokyo, Japan
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Sep 2007 (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 purpose of this study is to examine the efficacy of Technique Kangourou (TK) between low birth weight (LBW) infants and their mothers started as soon as possible within 24 hours after birth in developing country.
For the purpose of this study, TK is defined as skin-to-skin direct and continuous (24 hours) contact between LBW infants and their mothers or any other people who substitute mothers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: TK as soon as possible within 24 hours after birth |
| B | Active comparator | Other: Conventional care |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth weight (BW) < 2500g
- Delivery at maternity of CHUM (Birth < 24 hours)
- Without serious congenital malformation
- Sat O2 >=95％, HR > 100 / min, RR < 60 / min, Capillary refilling time < 3 sec
- The mother and the family are motivated to practice TK.
Key exclusion criteria (2 listed)
- Apnea of prematurity >20 sec
- With intravenous infusion
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 |
|---|---|---|
| TK as soon as possible within 24 hours after birthStart TK as soon as possible within 24 hours after birth | Behavioural | A |
| Conventional careStart conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready) | Other | B |
Primary outcome
Mortality within 28 days after birth
Time frame: within 28 days after birth
15 secondary outcomes
Mobility within 28 days after birth
Time frame: within 28 days after birth
Mortality and Mobility within 28 days after birth
Time frame: within 28 days after birth
Difference of (Baby's) loss in weight within 2 days
Time frame: within 2 days
Difference of (Baby's) Body weight of 14th day after birth
Time frame: 14th day after birth
Difference of (Baby's) Body weight of 28th day after birth
Time frame: 28th day after birth
Incidence of hypothermia during hospitalisation and (or) during outpatient department （lower than 35.5℃）
Time frame: Within 28 days after birth
Incidence of bradycardia or tachycardia during hospitalisation (HR <100, or>180 /min)
Time frame: within 28 days after birth
Incidence of apnea during hospitalisation (> 20 sec)
Time frame: within 28 days after birth
Incidence of desaturation during hospitalisation ( <87%)
Time frame: within 28 days after birth
Length of hospitalisation
Time frame: within 28 days after birth
Discharge within 7days after birth
Time frame: within 7days after birth
Mobility within 6 months or 1 year after birth
Time frame: within 6 months or 1 year
Mortality and Morbility within 6 months or 1 year after birth
Time frame: within 6 months or 1 year
Mortality within 6 months or 1 year after birth
Time frame: within 6 months or 1 year
Incidence of hyperthermia during hospitalisation and (or) outpatient department （upper than 37.5℃）
Time frame: Within 28 days after birth
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 Dec 2011.
- Results publication: PubMed 20121708Nagai S, Andrianarimanana D, Rabesandratana N, Yonemoto N, Nakayama T, Mori R. Earlier versus later continuous Kangaroo Mother Care (KMC) for stable low-birth-weight infants: a randomized controlled trial. Acta Paediatr. 2010 Jun;99(6):827-35. doi: 10.1111/j.1651-2227.2009.01676.x. Epub 2010 Jan 27.
- Results publication: PubMed 21635363Nagai S, Yonemoto N, Rabesandratana N, Andrianarimanana D, Nakayama T, Mori R. Long-term effects of earlier initiated continuous Kangaroo Mother Care (KMC) for low-birth-weight (LBW) infants in Madagascar. Acta Paediatr. 2011 Dec;100(12):e241-7. doi: 10.1111/j.1651-2227.2011.02372.x. Epub 2011 Jun 23.
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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.
Shuko Nagai, MD principal investigator
Groupe d'Etude de la Technique Kangourouà Mahajanga, Madagascar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TK as soon as possible within 24 hours after birth and Conventional care in people with Low Birth Weight, run by Foundation for Advanced Studies on International Development at 1 site in Madagascar.
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 6 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 Dec 2011. 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 Madagascar. 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?
Mortality within 28 days after birth (time frame: within 28 days after birth). 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 NCT00531492, which also lists 2 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 12 Dec 2011.