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Intact Cord Resuscitation in CDH (CHIC)

Primary Purpose

Rare Diseases, Congenital Diaphragmatic Hernia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immediate umbilical cord clamping
intact cord resuscitation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rare Diseases focused on measuring Congenital diaphragmatic hernia, resuscitation, delayed cord clamping, newborn

Eligibility Criteria

36 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Amiens PicardieRecruiting
  • Hop Jeanne de Flandre Chu LilleRecruiting
  • Chu de Nantes -Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Immediate umbilical cord clamping

Intact cord resuscitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.
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

Secondary Outcome Measures

Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml
Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml
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
Frequency of infants with the need for chest compressions
Frequency of infants with the need for epinephrine administration and/or fluid resuscitation
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;
plasma lactate concentration
these quantitative variables can be considered as objective markers of early cardiorespiratory adaptation at birth.
changes of global Blood gases parameters
pre- and postductal SpO2,
changes of ventilatory parameters
peak inspiratory pressure
changes of ventilatory parameters
respiratory rate
Volume of fluid resuscitation
Frequency of infants with the need for vasoactive drugs ;
Frequency of infants with the need for pulmonary vasodilator
Hemoglobin concentration
Infant mortality rate
Infant morbidity outcomes assessed within the first 90 days 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;
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).
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).
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).
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
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.
Cerebral Near-infrared spectroscopy recorded
Echographic parameters with the Resistive index and pulsatility index in the anterior cerebral artery
A parental questionnaire to assess neurological development (ASQ 3 score).

Full Information

First Posted
March 18, 2020
Last Updated
January 25, 2023
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04429750
Brief Title
Intact Cord Resuscitation in CDH
Acronym
CHIC
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rare Diseases, Congenital Diaphragmatic Hernia
Keywords
Congenital diaphragmatic hernia, resuscitation, delayed cord clamping, newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate umbilical cord clamping
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intact cord resuscitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Immediate umbilical cord clamping
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
intact cord resuscitation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of infants with APGAR score < 4 at 1 min or < 7 at 5 min.
Time Frame
during the first ten minutes after birth
Title
APGAR score
Description
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 birth
Secondary Outcome Measure Information:
Title
Frequency of postpartum hemorrhage (PPH) defined by blood loss ≥ 500 ml
Time Frame
during the deliverance time
Title
Frequency of severe PPH, defined by measured blood loss ≥ 1000 ml
Time Frame
during the deliverance time
Title
Blood loss volume after birth
Description
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 birth
Title
Frequency of infants with the need for chest compressions
Time Frame
during the deliverance time
Title
Frequency of infants with the need for epinephrine administration and/or fluid resuscitation
Time Frame
during the deliverance time
Title
Heart rate
Description
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;
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
Title
plasma lactate concentration
Description
these quantitative variables can be considered as objective markers of early cardiorespiratory adaptation at birth.
Time Frame
at one hour after birth (H1): at 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Title
changes of global Blood gases parameters
Description
pre- and postductal SpO2,
Time Frame
at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Title
changes of ventilatory parameters
Description
peak inspiratory pressure
Time Frame
at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Title
changes of ventilatory parameters
Description
respiratory rate
Time Frame
at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
Title
Volume of fluid resuscitation
Time Frame
during the first 24 hours
Title
Frequency of infants with the need for vasoactive drugs ;
Time Frame
during the first 24 hours
Title
Frequency of infants with the need for pulmonary vasodilator
Time Frame
during the first 24 hours
Title
Hemoglobin concentration
Time Frame
at 24 hours
Title
Infant mortality rate
Time Frame
at 90-day after birth
Title
Infant morbidity outcomes assessed within the first 90 days after birth
Time Frame
at 90-day after birth
Title
Number of refusal of participating to the protocol.
Description
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;
Time Frame
at the end of the study period (90±7 days after birth)
Title
State Trait Anxiety Inventory (STAI) revised version, form Y
Description
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).
Time Frame
within the first 48 hours after birth, and at the end of the study period (90±7 days after birth).
Title
the Impact of Event Scale-Revised (IES-R)
Description
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).
Time Frame
during the 7 days prior to completion and at the end of the study period (90±7 days after birth).
Title
the Intolerance for Uncertainty Scale (EII).
Description
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).
Time Frame
at the end of the study period (90±7 days after birth).
Title
Semi-structured interviews
Description
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
Time Frame
at the end of the study period (12 months after birth)
Title
the 'faceless' acute neonatal pain scale (FANS)
Description
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.
Time Frame
during intubation
Title
Cerebral Near-infrared spectroscopy recorded
Time Frame
at H1, H2, H6, H12, H24, H48
Title
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
Title
A parental questionnaire to assess neurological development (ASQ 3 score).
Time Frame
at M6 and M12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Storme, MD,PhD
Phone
03 20 44 61 99
Ext
+33
Email
laurent.storme@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Storme, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Name
Hop Jeanne de Flandre Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
Facility Name
Chu de Nantes -
City
Nantes
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Intact Cord Resuscitation in CDH

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