Delayed cord clamping in preterm neonates 30 to 33 weeks: A randomized controlled trial

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/02/004414
• Date of registration: 18-02-2014
• Prospective Registration: No
• Primary sponsor: PGIMER
• Public title: Delayed cord clamping in preterm neonates 30 to 33 weeks: A randomized controlled trial
• Scientific title: Placental transfusion in delivery room in preterm neonates 30 to 33 6/7 weeks: An open label randomized controlled trial
• Date of first enrolment: 05-11-2012
• Target sample size: 434
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=7688
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr S Venkataseshan
• Affiliation: PGIMER, Chandigarh

• Name: Dr Praveen Kumar
• Affiliation: PGIMER, Chandigarh

Key inclusion & exclusion criteria

Inclusion criteria: 1)Imminently delivering mothers from 30 weeks to 33 6/7 weeks

2)Parents have given informed consent.


Exclusion criteria: 1)Major congenital malformation incompatible for life diagnosed or suspected antenatally

2)Multiple pregnancy

3)Conditions where placental transfusion by delaying cord clamping could further compromise the just delivered neonate due to the additional blood volume being transfused such as antenatally diagnosed hydrops fetalis (irrespective of etiology or type of hydrops)



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- preterm neonates at birth

Intervention(s)

Intervention1: Delayed cord clamping: Step 1 (delayed cord clamping for 60 seconds from the birth of the baby): A birth attendant holds the baby as low as possible, but without causing cord traction, below the level of introitus or placenta for 60 seconds. In case the baby is depressed and needs resuscitation, the cord will be clamped immediately keeping it as long as possible, and it will be milked for three times towards the baby whilst resuscitation continues.
Control Intervention1: Early cord clamping: Early cord clamping group (10 seconds from birth of the baby): Umbilical cord will be clamped about 6cms from the neonate within 10 seconds from birth by holding the neonate at the level of the vaginal introitus (in cases of vaginal deliveries) and at the level of the placenta (in cases of cesarean section deliveries).

Primary Outcome(s)

composite outcome measure of all cause mortality and/or abnormal neurological examination at 40 weeks postnatal ageTimepoint: At 40 weeks postnatal age

Secondary Outcome(s)

Incidence of following at 40 weeks postnatal age :

1. All cause mortality

2. Intraventricular hemorrhage

3. bronchopulmonary dysplasia

4. Necrotizing enterocolitis

5. Retinopathy of prematurity

6. Hematocrit, number of blood transfusions

7. Significant hyperbilirubinemia

8. Serum ferritin levels at discharge and 3 months postnatal ageTimepoint: 40 weeks postnatal age, 3 moths postnatal age

Secondary ID(s)

NIL

Source(s) of Monetary Support

PGIMER chandigarh

Ethics review

Status: Approved
Approval date: 03/10/2013
Contact:

PGIMER Ethics ommittee