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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

27 Jan 2016

The date of last modification

Jan 29, 2019



Application Summary


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


Trial Details


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

  1. Medically uncomplicated, singleton pregnancies admitted to the Professorial Unit, De Soysa Hospital for Women
  2. Rhesus positive mothers
  3. Normal antenatal scans
  4. Elective caesarean section after a gestation of 37 weeks

Exclusion criteria

  1. Babies who do not spontaneously breath within the first 10 seconds of life
  2. Babies with a tight nuchal cord, babies with gross congenital anomaly diagnosed at birth
  3. Babies with birth weights less than the tenth percentile and babies with hydrops
  4. Babies who require resuscitation at birth or require admission to the neonatal unit at birth due to respiratory distress or cyanosis


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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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