Rare DiseasesCHICNCT04429750
Intact Cord Resuscitation in CDH
A study testing Immediate umbilical cord clamping and intact cord resuscitation in people with Rare Diseases and Congenital Diaphragmatic Hernia, run by University Hospital, Lille at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 36 to 37 weeks
- Conditions the study is for
- Rare Diseases, Congenital Diaphragmatic Hernia
- What is being tested?
- Immediate umbilical cord clamping and intact cord resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Oct 2020to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Chu Amiens Picardie
Amiens
- Recruiting
Hop Jeanne de Flandre Chu Lille
Lille, 59037
0320445962
- Recruiting
Chu de Nantes -
Nantes
About this study
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)
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.
- Conditions
- Rare Diseases, Congenital Diaphragmatic Hernia
- Being tested
- Immediate umbilical cord clamping, intact cord resuscitation
- Keywords
- Congenital diaphragmatic hernia, resuscitation, delayed cord clamping, newborn
- Medical subject headings
- Rare Diseases, Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate umbilical cord clampingProcedure or surgery
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 resuscitationProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Immediate umbilical cord clamping | Active comparator | This group includes newborn infants with isolated CDH who will benefit from the standardized CDH management procedure as described in the French national CDH management guidelines ("Programme National de Soins").The resuscitation maneuvers are started after the umbilical cord is clamped. Receives: Procedure: Immediate umbilical cord clamping |
| Intact cord resuscitation | Experimental | This group includes newborn infants with isolated CDH who will benefit from the standardized CDH resuscitation maneuvers as described in the French national CDH management guidelines ("Programme National de Soins") before the umbilical cord is clamped. The resuscitation maneuvers are started at birth while the umbilical cord still bridges mother and child. Receives: Procedure: intact cord resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.
Measured: during the first ten minutes after birth
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
Measured: during the first ten minutes after birth
Secondary outcomes (25)
Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml
Measured: during the deliverance time
Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml
Measured: during the deliverance time
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
Measured: at 15 minutes after birth, at 1hours after birth
Frequency of infants with the need for chest compressions
Measured: during the deliverance time
Frequency of infants with the need for epinephrine administration and/or fluid resuscitation
Measured: during the deliverance time
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;
Measured: at 1, 5, and 10 min after birth and at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
plasma lactate concentration
these quantitative variables can be considered as objective markers of early cardiorespiratory adaptation at birth.
Measured: at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
changes of global Blood gases parameters
pre- and postductal SpO2,
Measured: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
changes of ventilatory parameters
peak inspiratory pressure
Measured: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
changes of ventilatory parameters
respiratory rate
Measured: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Volume of fluid resuscitation
Measured: during the first 24 hours
Frequency of infants with the need for vasoactive drugs ;
Measured: during the first 24 hours
Frequency of infants with the need for pulmonary vasodilator
Measured: during the first 24 hours
Hemoglobin concentration
Measured: at 24 hours
Infant mortality rate
Measured: at 90-day after birth
Infant morbidity outcomes assessed within the first 90 days after birth
Measured: at 90-day after birth
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;
Measured: at the end of the study period (90±7 days after birth)
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).
Measured: within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).
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).
Measured: during the 7 days prior to completion and at the end of the study period (90±7 days after birth).
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).
Measured: at the end of the study period (90±7 days after birth).
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
Measured: at the end of the study period (12 months after birth)
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.
Measured: during intubation
Cerebral Near-infrared spectroscopy recorded
Measured: at H1, H2, H6, H12, H24, H48
Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery
Measured: at H6, H24, H24 after the chirurgical CDH repair gesture, H48, D7, D28
A parental questionnaire to assess neurological development (ASQ 3 score).
Measured: at M6 and M12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start8 Oct 2020
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Laurent Storme, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429750
- Sponsor's protocol ID
- 2018_94
- Other IDs
- 2019-A01030-57, PHRC-18-0234
- Acronym
- CHIC
- Status last verified
- May 2026
- First submitted
- 18 Mar 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04429750
- Acronym / sponsor ID
- CHIC / 2018_94
- Conditions
- Rare Diseases, Congenital Diaphragmatic Hernia
- Keywords
- Congenital diaphragmatic hernia, resuscitation, delayed cord clamping, newborn
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate umbilical cord clamping | Active comparator | Procedure: Immediate umbilical cord clampingThis group includes newborn infants with isolated CDH who will benefit from the standardized CDH management procedure as described in the French national CDH management guidelines ("Programme National de Soins").The resuscitation maneuvers are started after the umbilical cord is clamped. |
| Intact cord resuscitation | Experimental | Procedure: intact cord resuscitationThis group includes newborn infants with isolated CDH who will benefit from the standardized CDH resuscitation maneuvers as described in the French national CDH management guidelines ("Programme National de Soins") before the umbilical cord is clamped. The resuscitation maneuvers are started at birth while the umbilical cord still bridges mother and child. |
Who may qualify
- Ages
- 36 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate umbilical cord clampingIn 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 or surgery | Immediate umbilical cord clamping |
| intact cord resuscitationThe 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). | Procedure or surgery | Intact cord resuscitation |
Primary outcome
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
25 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
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
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
changes of global Blood gases parameters
Time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
changes of ventilatory parameters
Time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
changes of ventilatory parameters
Time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Volume of fluid resuscitation
Time frame: during the first 24 hours
Frequency of infants with the need for vasoactive drugs ;
Time frame: during the first 24 hours
Frequency of infants with the need for pulmonary vasodilator
Time frame: during the first 24 hours
Hemoglobin concentration
Time frame: at 24 hours
Infant mortality rate
Time frame: at 90-day after birth
Infant morbidity outcomes assessed within the first 90 days after birth
Time frame: at 90-day after birth
Number of refusal of participating to the protocol.
Time frame: at the end of the study period (90±7 days after birth)
State Trait Anxiety Inventory (STAI) revised version, form Y
Time frame: within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).
the Impact of Event Scale-Revised (IES-R)
Time frame: during the 7 days prior to completion and at the end of the study period (90±7 days after birth).
the Intolerance for Uncertainty Scale (EII).
Time frame: at the end of the study period (90±7 days after birth).
Semi-structured interviews
Time frame: at the end of the study period (12 months after birth)
the 'faceless' acute neonatal pain scale (FANS)
Time frame: during intubation
Cerebral Near-infrared spectroscopy recorded
Time frame: at H1, H2, H6, H12, H24, H48
Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery
Time frame: at H6, H24, H24 after the chirurgical CDH repair gesture, H48, D7, D28
A parental questionnaire to assess neurological development (ASQ 3 score).
Time frame: at M6 and M12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Storme, MD,PhD principal investigator
University Hospital, Lille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate umbilical cord clamping and intact cord resuscitation in people with Rare Diseases and Congenital Diaphragmatic Hernia, run by University Hospital, Lille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Storme, MD,PhD (03 20 44 61 99 ext. +33, laurent.storme@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min. (time frame: during the first ten minutes after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.