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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
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).
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).
Chu Amiens Picardie
Amiens, France
RECRUITINGHop Jeanne de Flandre Chu Lille
Lille, France
RECRUITINGChu de Nantes -
Nantes, France
RECRUITINGNumber 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
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
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
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
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
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
plasma lactate concentration
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
changes of global Blood gases parameters
pre- and postductal SpO2,
Time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
changes of ventilatory parameters
peak inspiratory pressure
Time frame: at 1hour , 24 hours, 48 hours, 72 hours, at 7 days and at 28 days
changes of ventilatory parameters
respiratory rate
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.
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)
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).
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)
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).
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).
Time frame: 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
Time frame: 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.
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.