Home » Trials » SLCTR/2016/003
A randomized controlled trial on the effect of delayed cord clamping and immediate skin to skin contact between mother and baby compared to early cord clamping and early skin to skin contact on neonatal behaviour and infant development
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SLCTR Registration Number
SLCTR/2016/003
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
A randomized controlled trial on the effect of delayed cord clamping and immediate skin to skin contact between mother and baby compared to early cord clamping and early skin to skin contact on neonatal behaviour and infant development
Public Title of Trial
A randomized controlled trial on the effect of delayed cord clamping and immediate skin to skin contact between mother and baby compared to early cord clamping and early skin to skin contact on neonatal behaviour and infant development
Disease or Health Condition(s) Studied
Neonatal behaviour and infant development
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1176-8293
Any other number(s) assigned to the trial and issuing authority
EC-14-188 Ethics Review Committee, Faculty of Medicine University of Colombo, Sri Lanka
What is the research question being addressed?
Does delayed cord clamping and immediate skin to skin contact between mother and baby improve neonatal behaviour and infant development when compared to early cord clamping and early skin to skin contact in babies delivered by elective caesarian section at term?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Active
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at the University Unit, De Soysa Hospital for Women, Colombo, Sri Lanka.
Consenting participants meeting inclusion/exclusion criterial will be allocated into four arms using block randomization
The 4 groups are as follows:
A. Immediate skin to skin contact and early cord clamping group
B. Immediate skin to skin contact and late cord clamping group
C. Early skin to skin contact and early cord clamping
D. Early skin to skin contact and late cord clamping
Definitions
Immediate skin to skin contact: contact is within the 1st minute after birth
Early skin to skin contact: contact is within 30 minutes of birth.
At the end of a period of three minutes of skin contact, the baby will be taken out by the neonatal team by taking the baby in a cephalad direction. The current practice in caesarean sections is for early skin to skin contact with the mother –all babies are breast fed before they leave the theatre. This will be continued in Groups C & D, except that in Group D the baby will be kept on the upper surgical drape or on her lap after drying until clamping of the cord.
Early cord clamping will be defined as done immediately (within 90 seconds) after delivery of the baby
Late cord clamping will be defined as done after 90 seconds of delivering the baby.
The investigators who will assess the outcomes will be blinded to the intervention provided.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Neonatal Behaviour Assessment Scores |
[ Neonatal Behaviour Assessment Scores: at first three days, at 2-3 weeks and at 2 months of age ] |
|
2.
Development scores (raw, scaled and composite) in gross motor, fine motor, expressive speech, receptive speech, cognitive and social / adaptive development assessed via Bayley III infant and toddler scales |
[ At 6, 12, 18 and 36 months ] |
|
3.
Exclusive breast feeding rates |
[ At 2 weeks, 2 months and six months ] |
|
4.
Rates of respiratory distress requiring intervention |
[ At birth, and then three times daily within the first three days of life until discharge ] |
|
5.
Occurrence of hyperbilirubinaemia warranting phototherapy (detected clinically and confirmed with serum bilirubin) |
[ Three times daily within the first three days of life until discharge ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
377
Countries of recruitment
Sri Lanka
Anticipated start date
2016-01-27
Anticipated end date
2019-05-31
Date of first enrollment
2016-02-03
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2015-02-19
Approval number
EC-14-188
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof H.M. Senanayake
Professor
Department of Obstetrics and Gynaecology,
Faculty of Medicine, University of Colombo,
No 25, Kynsey Road, Colombo 8,
Sri Lanka
Tel: +94 112695300
Mob: +94714762176
Fax: +94 112691581
senanayakeh@gmail.com
Contact Person for Public Queries
Prof H.M. Senanayake
Professor
Department of Obstetrics and Gynaecology,
Faculty of Medicine, University of Colombo,
No 25, Kynsey Road, Colombo 8,
Sri Lanka
Tel: +94 112695300
Mob: +94714762176
Fax: +94 112691581
senanayakeh@gmail.com
Primary study sponsor/organization
Department of Obstetrics and Gynaecology,
Faculty of Medicine, University of Colombo,
No 25, Kynsey Road, Colombo 8,
Sri Lanka
Tel: +94 112695300 (ext 161)
Fax: +94 112691581
http://www.med.cmb.ac.lk/index.php/2012-05-16-05-13-13/obstetrics-and-gynaecology
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
