Clinical trial NCT04429750: Intact Cord Resuscitation in CDH
Official title: Efficacy of Intact Cord Resuscitation Compared to Immediate Cord Clamping on Cardiorespiratory Adaptation at Birth in Infants With Isolated Congenital Diaphragmatic Hernia (CDH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rare Diseases
Congenital Diaphragmatic Hernia
Keywords: Congenital diaphragmatic hernia
resuscitation
delayed cord clamping
newborn
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2020-06-12
Enrollment: 180
Sex: ALL
Minimum age (years): 36
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.
timeFrame: during the first ten minutes after birth
measure: APGAR score
timeFrame: during the first ten minutes after birth
Secondary outcomes:
measure: Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml
timeFrame: during the deliverance time
measure: Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml
timeFrame: during the deliverance time
measure: Blood loss volume after birth
timeFrame: at 15 minutes after birth, at 1hours after birth
measure: Frequency of infants with the need for chest compressions
timeFrame: during the deliverance time
measure: Frequency of infants with the need for epinephrine administration and/or fluid resuscitation
timeFrame: during the deliverance time
measure: Heart rate
timeFrame: at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
measure: plasma lactate concentration
timeFrame: at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
measure: changes of global Blood gases parameters
timeFrame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
measure: changes of ventilatory parameters
timeFrame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
measure: changes of ventilatory parameters
timeFrame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
measure: Volume of fluid resuscitation
timeFrame: during the first 24 hours
measure: Frequency of infants with the need for vasoactive drugs ;
timeFrame: during the first 24 hours
measure: Frequency of infants with the need for pulmonary vasodilator
timeFrame: during the first 24 hours
measure: Hemoglobin concentration
timeFrame: at 24 hours
measure: Infant mortality rate
timeFrame: at 90-day after birth
measure: Infant morbidity outcomes assessed within the first 90 days after birth
timeFrame: at 90-day after birth
measure: Number of refusal of participating to the protocol.
timeFrame: at the end of the study period (90±7 days after birth)
measure: State Trait Anxiety Inventory (STAI) revised version, form Y
timeFrame: within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).
measure: the Impact of Event Scale-Revised (IES-R)
timeFrame: during the 7 days prior to completion and at the end of the study period (90±7 days after birth).
measure: the Intolerance for Uncertainty Scale (EII).
timeFrame: at the end of the study period (90±7 days after birth).
measure: Semi-structured interviews
timeFrame: at the end of the study period (12 months after birth)
measure: the 'faceless' acute neonatal pain scale (FANS)
timeFrame: during intubation
measure: Cerebral Near-infrared spectroscopy recorded
timeFrame: at H1, H2, H6, H12, H24, H48
measure: Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery
timeFrame: at H6, H24, H24 after the chirurgical CDH repair gesture, H48, D7, D28
measure: A parental questionnaire to assess neurological development (ASQ 3 score).
timeFrame: at M6 and M12
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
city: Nantes
country: France
facility: Chu de Nantes -
Study officials:
affiliation: University Hospital, Lille
name: Laurent Storme, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: