Intact Cord Resuscitation in CDH

NCT04429750 | Unknown DMC

• 3 other identifiers: 2018_942019-A01030-57PHRC-18-0234
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in France and abroad. Several studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. Previous works also suggest a possible benefit of this procedure for babies with CDH. This multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated CDH.

Conditions

Rare Diseases; Congenital Diaphragmatic Hernia

Keywords

Congenital diaphragmatic hernia; resuscitation; delayed cord clamping; newborn

Outcome Measures

Primary Outcomes (2)

• Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.

  during the first ten minutes after birth

• APGAR score

  APGAR at 1, 5 and 10 minutes after birth will be reassessed retrospectively by a final observer. The reassessment will be carried out using a video of the first 10 minutes of life of the newborn filmed with a camera if the parents agree. This video will only record the appearance of babies' bodies and faces

  during the first ten minutes after birth

Secondary Outcomes (25)

• Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml

  during the deliverance time

• Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml

  during the deliverance time

• Blood loss volume after birth

  at 15 minutes after birth, at 1hours after birth

• Frequency of infants with the need for chest compressions

  during the deliverance time

• Frequency of infants with the need for epinephrine administration and/or fluid resuscitation

  during the deliverance time

Study Arms (2)

Immediate umbilical cord clamping

ACTIVE COMPARATOR

This group includes newborn infants with isolated CDH who will benefit from the standardized CDH management procedure as described in the French national CDH management guidelines ("Programme National de Soins").The resuscitation maneuvers are started after the umbilical cord is clamped.

Procedure: Immediate umbilical cord clamping

Intact cord resuscitation

EXPERIMENTAL

This group includes newborn infants with isolated CDH who will benefit from the standardized CDH resuscitation maneuvers as described in the French national CDH management guidelines ("Programme National de Soins") before the umbilical cord is clamped. The resuscitation maneuvers are started at birth while the umbilical cord still bridges mother and child.

Procedure: intact cord resuscitation

Interventions

Immediate umbilical cord clamping PROCEDURE

In the immediate cord clamping group, the umbilical cord will be clamped within the first 20 seconds after birth and the infant will be transferred to the resuscitation room. The newborn infant will be intubated and mechanically ventilated as quickly as possible on the resuscitation table as recommended in the French "Programme National de Soins". After cardiorespiratory stabilization (i.e. heart rate\>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%), the infant will be transferred to the neonatal intensive care unit (NICU). Oxytocin is infused to the mother as recommended in the local protocol (usually just after birth or cord clamping).

Immediate umbilical cord clamping

intact cord resuscitation PROCEDURE

The umbilical cord will be kept intact during the initial phase of the resuscitation. The infant will be placed on a specifically designed compact trolley with a warmed platform, suitable for commencing resuscitation between the mother's legs in case of vaginal birth or near the operating table beside the mother in case of cesarean section. This trolley will be fully equipped for resuscitation, including a suction device, gas flowmeter/blender, ventilatory support, and monitoring system. Its height can be adjusted in order to position the infant close to the maternal perineum. The infant will be intubated and mechanically ventilated on this trolley. The cord will be clamped once cardiorespiratory stabilization will be obtained (i.e. heart rate\>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%) or in case of spontaneous placental expulsion. The infant will be then transferred to the neonatal intensive care unit (NICU).

Intact cord resuscitation

Eligibility Criteria

• Age: 36 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Antenatal diagnosis of CDH
• No severe additional malformation or chromosomal diseases
• Full term (\>36 weeks gestational age)
• Written informed consents from the parents

You may not qualify if:

• Preterm birth less than 37 weeks gestational age
• Other severe malformation(s) or chromosomal diseases
• Twin
• Parents who may have French language understanding difficulties may not participate to the study unless they receive appropriate assistance regarding the understanding of the formal consent forms needed to get included in the study. If included in the study, regarding their French understanding level, the parents may not be proposed the auto questionnaires and interviews led by the psychologist

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (3)

Chu Amiens Picardie

Amiens, France

RECRUITING

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

RECRUITING

Chu de Nantes -

Nantes, France

RECRUITING

MeSH Terms

Conditions

Rare Diseases; Hernias, Diaphragmatic, Congenital

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Laurent Storme, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent Storme, MD,PhD

CONTACT

03 20 44 61 99; laurent.storme@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: June 12, 2020
• Study Start: October 8, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

FR (3)