Intact Cord Resuscitation in CDH
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age36-37
SponsorUniversity Hospital, Lille
About this trial
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
Qualifiers
Antenatal diagnosis of CDH
No severe additional malformation or chromosomal diseases
Full term (>36 weeks gestational age)
No inclusion in another antenatal trial
Disqualifiers
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
Trial design
Treatments tested in this trial
- Immediate umbilical cord clamping
- intact cord resuscitation
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator
Source ClinicalTrials.gov