Current partner codePEPTIDESDE
NCT04429750·Not applicable·INTERVENTIONAL

Intact Cord Resuscitation in CDH

Status

Recruiting

Phase

Not applicable

Enrollment

180

Locations

3

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

PROCEDURE

Immediate umbilical cord clamping

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).

PROCEDURE

intact cord resuscitation

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).

Timeline

From registration to results.

  1. First posted

    Jun 12, 2020

  2. Study start

    Oct 8, 2020

  3. Primary completion

    Oct 2026

  4. Study completion

    Oct 2026

  5. Results posted

    Not reported

  6. Registry updated

    May 20, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · during the first ten minutes after birth

APGAR score

Time frame · during the first ten minutes after birth

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

Secondary outcomes

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

Time frame · during the deliverance time

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

Time frame · during the deliverance time

Blood loss volume after birth

Time frame · at 15 minutes after birth, at 1hours after birth

the collector bag will have to be left in place at least 15 minutes to have one measure of blood loss at the same time point in all women

Frequency of infants with the need for chest compressions

Time frame · during the deliverance time

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

Time frame · during the deliverance time

Heart rate

Time frame · at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days

a pulse oximeter sensor will be placed at the right hand as soon as possible (within the first minute after birth), which then will be connected to a pulse oximeter;

plasma lactate concentration

Time frame · at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days

these quantitative variables can be considered as objective markers of early cardiorespiratory adaptation at birth.

changes of global Blood gases parameters

Time frame · at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days

pre- and postductal SpO2,

changes of ventilatory parameters

Time frame · at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days

peak inspiratory pressure

changes of ventilatory parameters

Time frame · at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days

respiratory rate

Eligibility

Who can take part.

Minimum age
36 Weeks
Maximum age
37 Weeks
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Antenatal diagnosis of CDH * No severe additional malformation or chromosomal diseases * Full term (\>36 weeks gestational age) * No inclusion in another antenatal trial * Written informed consents from the parents Exclusion Criteria: * 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

Study locations

3 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Chu Amiens Picardie

Amiens, France

Hop Jeanne de Flandre Chu Lille

Lille, France

Chu de Nantes -

Nantes, France

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.