Supine vs Prone Position During Delayed Cord Clamping

NCT03697967 | Completed

• 1 other identifier: 2019-1594
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to evaluate if the prone position of the newborn on the chest of his mother at birth before delayed cord clamping leads to better hematocrit and hemoglobin at 24-48 hours of life compared to supine position.

Conditions

Newborn; Anemia; Umbilical Cord Problem

Keywords

Delayed cord clamping

Outcome Measures

Primary Outcomes (1)

• Hemoglobin and hematocrit

  Hemoglobin value

  24-48 hours

Secondary Outcomes (2)

• Cerebral saturation by near infrared spectroscopy (NIRS)

  24-48 H of life

• Bilirubin

  24-48 hours

Study Arms (2)

Supine

EXPERIMENTAL

Infant placed supine for 120 seconds before cord clamping

Procedure: supine or prone position

Prone

EXPERIMENTAL

Infant placed prone for 120 seconds before cord clamping

Procedure: supine or prone position

Interventions

supine or prone position PROCEDURE

Before delivery, a sealed enveloppe is opened by the physician or nurse present at delivery. Immediately at birth the team in charge of delivery place the newborn in skin to skin contact on the mother's chest where he is dried. Umbilical cord clamping is delayed in both intervention arms to 1 minute after birth. The newborn is placed in the prone or in the supine position depending on allocation. The nurse in charge of the newborn uses a stopwatch to check the time at which clamping was accomplished. All subsequent nursery care are conducted according to hospital protocol.

Also known as: delay cord clamping

Prone; Supine

Eligibility Criteria

• Age: 1 Minute - 2 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborn ≥ 36 weeks gestational age and Born vaginally and Well appearing

You may not qualify if:

• Out born infant, Infant born by caesarian section, Preterm born less than 36 weeks GA, Infant with intra uterine growth restriction (IUGR: less than 10th percentile) Asphyxiated infant Infant needing immediate resuscitation, Newborn with malformation (gastroschisis, omphalocele, anal atresia, severe head skin injury, congenital cardiac disease Newborn with mother with preeclampsia or gestational hypertension or diabetes on insuline or hemolytic disease or on chemotherapy or on cortisone.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Brahim Bensouda

Montreal East, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Anemia, Neonatal

Interventions

Supine Position; Prone Position

Condition Hierarchy (Ancestors)

Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomised two arms study

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 5, 2018
• Study Start: March 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)