Supine vs Prone Position During Delayed Cord Clamping

Newborn; Anemia Clinical Trial

— DCC  

Official title:

Supine vs Prone Position During Delayed Cord Clamping in Term Infants A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697967
• Other study ID #: 2019-1594
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: April 2022
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

At 30 hours of life, laboratory personnel drew a capillary sample from the infant's heel for hemoglobin, hematocrit, and total serum bilirubin at the same time as the newborn metabolic screening sample. There is no added heelstick to routine care, as current standard in our institution requires the bilirubin to be drawn at 30 hours of life.

During universal screening for congenital cardiac defects (30 hours of life), a value of cerebral saturation (CrSO2) is measured using NIRS with INVOS (In Vivo Optical Spectroscopy, INVOS System, Covidien, Dublin, Ireland, Somanetics). Sensors are placed over the forehead and the newborn is in supine position.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Minutes

Eligibility

Inclusion Criteria:

Newborn = 36 weeks gestational age and Born vaginally and Well appearing

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Anemia, Neonatal
• Newborn; Anemia
• Umbilical Cord Problem

Intervention

Procedure:
• supine or prone position
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.

Locations

Country	Name	City	State
Canada	Brahim Bensouda	Montréal-Est	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin and hematocrit	Hemoglobin value	24-48 hours
Secondary	Cerebral saturation by near infrared spectroscopy (NIRS)	Cerebral saturation by near infrared spectroscopy	24-48 H of life
Secondary	Bilirubin	Bilirubin value	24-48 hours