Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04429750
Other study ID # 2018_94
Secondary ID 2019-A01030-57PH
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2020
Est. completion date October 2025

Study information

Verified date January 2023
Source University Hospital, Lille
Contact Laurent Storme, MD,PhD
Phone 03 20 44 61 99
Email laurent.storme@chru-lille.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 36 Weeks to 37 Weeks
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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).

Locations

Country Name City State
France Chu Amiens Picardie Amiens
France Hop Jeanne de Flandre Chu Lille Lille
France Chu de Nantes - Nantes

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min. during the first ten minutes after birth
Primary 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 Frequency of postpartum hemorrhage (PPH) defined by blood loss = 500 ml during the deliverance time
Secondary Frequency of severe PPH, defined by measured blood loss = 1000 ml during the deliverance time
Secondary 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 at 15 minutes after birth, at 1hours after birth
Secondary Frequency of infants with the need for chest compressions during the deliverance time
Secondary Frequency of infants with the need for epinephrine administration and/or fluid resuscitation during the deliverance time
Secondary Heart rate 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; at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Secondary plasma lactate concentration these quantitative variables can be considered as objective markers of early cardiorespiratory adaptation at birth. at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Secondary changes of global Blood gases parameters pre- and postductal SpO2, at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Secondary changes of ventilatory parameters peak inspiratory pressure at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Secondary changes of ventilatory parameters respiratory rate at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Secondary Volume of fluid resuscitation during the first 24 hours
Secondary Frequency of infants with the need for vasoactive drugs ; during the first 24 hours
Secondary Frequency of infants with the need for pulmonary vasodilator during the first 24 hours
Secondary Hemoglobin concentration at 24 hours
Secondary Infant mortality rate at 90-day after birth
Secondary Infant morbidity outcomes assessed within the first 90 days after birth at 90-day after birth
Secondary Number of refusal of participating to the protocol. the reasons for refusal will be recorded : do not want to participate to a research protocol, to not want to be randomized in the immediate cord clamping group, to not want to be randomized in the intact cord resuscitation group; at the end of the study period (90±7 days after birth)
Secondary State Trait Anxiety Inventory (STAI) revised version, form Y The STAI is a self-report scale translated in French (1). The scale includes 20 questions, and takes approximately 5 minutes to complete. It is widely used and usually well accepted. Both parents will be requested to answer the questionnaire at two distinct moments. The first will be within the first 48 hours after birth, and the second will be during the medical consultation at the end of the study period (90±7 days after birth). within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).
Secondary the Impact of Event Scale-Revised (IES-R) The IES-R is made up of 22 items aimed at assessing three main factors of traumatic symptoms (intrusion, avoidance and numbing, and hyperarousal) linked to a specific stressful event. The questions pertain to symptoms occurring during the 7 days prior to completion. The scale usually takes approximately 5 minutes to complete. Parents will be requested to answer the questionnaire during the medical consultation at the end of the study period (90±7 days after birth). during the 7 days prior to completion and at the end of the study period (90±7 days after birth).
Secondary the Intolerance for Uncertainty Scale (EII). This self-report scale was originally designed in French and includes 27 questions pertaining to the beliefs and representations held by individuals with regards to uncertainty. The scale is usually completed in approximately 10 minutes. Parents will be requested to answer the questionnaire during the medical consultation at the end of the study period (90±7 days after birth). at the end of the study period (90±7 days after birth).
Secondary Semi-structured interviews Semi-structured interviews will be proposed by a psychologist to the parents whatever the issue, to assess their personal experience of the resuscitating period at birth, including both early/delayed cord clamping and close/remote resuscitation maneuvers. The interviews tape recordings will be transcribed and then analyzed using thematic coding. The anonymized data will be independently coded by three researchers and compared for consistency of interpretation. The themes that emerged following the final coding will be used for a qualitative analysis of the parental verbatim; Due to he's or her's initial condition (HCD), if the newborn dies before the end of the study, the parents will not be asked to get through the psychological questionnaires and interviews at the end of the study period (12 months after birth)
Secondary the 'faceless' acute neonatal pain scale (FANS) FANS, which doesn't include items on facial expression, is particularly adapted for evaluating acute pain in newborns during intubation. Pain assessment is based on the analysis of limb movement, vocal expression and autonomic reactions, including heart rate variations and the occurrence of bradycardia or desaturation. during intubation
Secondary Cerebral Near-infrared spectroscopy recorded at H1, H2, H6, H12, H24, H48
Secondary Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery at H6, H24, H24 after the chirurgical CDH repair gesture, H48, D7, D28
Secondary A parental questionnaire to assess neurological development (ASQ 3 score). at M6 and M12
See also
  Status Clinical Trial Phase
Recruiting NCT05794217 - A Multi-Site Leukopak Repository Providing Annotated Biospecimens for Approved Investigator-Directed Biomedical Research Initiatives
Completed NCT03680365 - Your Voice; Impact of Duchenne Muscular Dystrophy (DMD) on the Lives of Families
Completed NCT03290469 - NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants N/A
Not yet recruiting NCT05955794 - Vocal Pattern Assessment as a New Key to Identifying Rare Syndromes N/A
Not yet recruiting NCT04152876 - Functional Genomics of Rare Genetic Diseases: Realization of Innovative Tools With High Diagnostic Power
Recruiting NCT03683966 - MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study
Not yet recruiting NCT04319796 - European Registry on Rare Neurological Diseases
Completed NCT02736565 - Pbi-shRNA™ EWS/FLI1 Type 1 LPX in Subjects With Advanced Ewing's Sarcoma Phase 1
Completed NCT05070988 - Oral Health Related Quality of Life of Patients With Rare Diseases: a Qualitative Approach
Completed NCT03563677 - Dual Guidance Structure for Evaluation of Patients With Unclear Diagnosis in Centers for Rare Diseases N/A
Recruiting NCT05499091 - Functional Study to Indentify Genetic Etiology of Rare Diseases - ORIGIN N/A
Completed NCT03954652 - Whole Genome Trio Sequencing as a Standard Routine Test in Patients With Rare Diseases - "GENOME FIRST APPROACH" N/A
Recruiting NCT05703893 - Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
Enrolling by invitation NCT04703179 - Rare and Undiagnosed Disease Research Biorepository
Recruiting NCT04024774 - Diagnostic Research in Patients With Rare Diseases -Solving the Unsolved Rare Diseases
Recruiting NCT06343558 - Gait and Balance Impairment in Rare and Very Rare Neurological Diseases
Not yet recruiting NCT06412718 - Validation of Human Drugs Target of Repurposed Drugs and Novel Therapies
Enrolling by invitation NCT04654000 - Rheopheresis as Adjuvant Treatment of Calciphylaxis N/A
Recruiting NCT04651439 - Severe Bullous Drug Eruption and Filgrastim Phase 2/Phase 3
Recruiting NCT03491280 - Diagnostic Research in Patients With Rare Diseases - Solving the Unsolved Rare Diseases