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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Immediate umbilical cord clamping
Procedure/SurgeryIn 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).
intact cord resuscitation
Procedure/SurgeryThe 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).
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Immediate umbilical cord clampingActive comparator 1 intervention
Group B: Intact cord resuscitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.
Time frame
during the first ten minutes after birth2
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
Time frame
during the first ten minutes after birthSecondary outcomes
1
Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml
Time frame
during the deliverance time2
Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml
Time frame
during the deliverance time3
Blood loss volume 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
Time frame
at 15 minutes after birth, at 1hours after birth4
Frequency of infants with the need for chest compressions
Time frame
during the deliverance timeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
Ministry of Health, France
Collaborator
Source ClinicalTrials.gov