University Hospital Center of Mahajanga (Centre Hospitalier Universitaire de Mahajanga: CHUM),
Mahajanga, Madagascar
Completed
NCT Number: NCT00531492
Efficacy of Continuous Skin to Skin Care (Technique Kangaroo: TK) After Birth for Low Birth Weight (LBW) Infants and Their Mothers in Developing Countries
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.
Completed
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Conditions
Age range
Up to 24 hour
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- Apnea of prematurity >20 sec
- With intravenous infusion
Treatment and study plan
TK as soon as possible within 24 hours after birth
BehavioralStart TK as soon as possible within 24 hours after birth
Conventional care
OtherStart conventional care (At first use incubator, and start TK when the infants and mother are completely settled and ready)
Primary outcomes
-
Mortality within 28 days after birth
Time frame: within 28 days after birth
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
Sponsors and collaborators
Lead sponsor
Foundation for Advanced Studies on International Development
Other
Collaborators
- St.Luke's Life Science Institute, Tokyo, Japan
Registry information
Official study 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
Acronym: EtudeTK
Important dates
- Study start
- 2007
- Primary completion
- 2008
- Study completion
- 2009
- First posted
- Sep 18, 2007
- Registry last updated
- Dec 12, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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