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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04373902




Registration number
NCT04373902
Ethics application status
Date submitted
14/04/2020
Date registered
5/05/2020
Date last updated
22/09/2023

Titles & IDs
Public title
Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia
Scientific title
Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial
Secondary ID [1] 0 0
NL7853
Secondary ID [2] 0 0
PinC trial
Universal Trial Number (UTN)
Trial acronym
PinC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hernias, Diaphragmatic, Congenital 0 0
Hernia; Diaphragm Defect, Congenital 0 0
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Physiological-based cord clamping

Experimental: Physiological-based cord clamping - In PBCC, the Concord will be placed next to the bed of the mother and all equipment will be checked before the second stage of labour has started. The infant will be placed on the platform of the Concord immediately after birth, avoiding any traction or pressure on the cord and avoiding heat loss by radiation heating. The umbilical cord will not be clamped until the infant is considered respiratory stable, which is defined as the presence of a heart rate >100 bpm and preductal oxygen saturation >85%, while using an fraction of inspired oxygen (FiO2) of <0.5. The minimum and maximum times of cord clamping are three and ten minutes after birth, respectively. Oxytocin administration will be postponed until after cord clamping if there are no obstetric concerns. At any time, the attending neonatologist and obstetrician can decide that PBCC should not be performed or be interrupted. In that case, the infant can be placed on the standard resuscitation table for (further) stabilisation.

No Intervention: Immediate cord clamping - In the immediate cord clamping group, the cord will be clamped immediately after birth. The infant will then be transferred to the standard neonatal resuscitation table. After cord clamping, all infants will be managed according to the standardised neonatal management protocol for infants with a CDH, which is a consensus of current clinical guidelines by the CDH EURO consortium.


Treatment: Surgery: Physiological-based cord clamping
See 'Arm'
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
Timepoint [1] 0 0
First 24 hours after birth
Secondary outcome [1] 0 0
Neonatal: mortality before discharge from the tertiary care hospital
Timepoint [1] 0 0
From birth till discharge from the tertiary care hospital, through study completion an average of one year
Secondary outcome [2] 0 0
Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
Timepoint [2] 0 0
The first 24 hours after delivery
Secondary outcome [3] 0 0
Neonatal: number of patients requiring ECMO therapy
Timepoint [3] 0 0
From admission to the ICU until the date of death or the date of discharge home, whichever came first
Secondary outcome [4] 0 0
Neonatal: number of days of duration of supplemental oxygen need
Timepoint [4] 0 0
From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
Secondary outcome [5] 0 0
Neonatal: number of days of duration of mechanical ventilation
Timepoint [5] 0 0
From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
Secondary outcome [6] 0 0
Neonatal: duration of admission to the tertiary care hospital
Timepoint [6] 0 0
From admission to the ICU until the date of discharge to another ward or home, whichever came first
Secondary outcome [7] 0 0
Maternal: number of patients with postpartum haemorrhage
Timepoint [7] 0 0
The first 24 hours after delivery

Eligibility
Key inclusion criteria
- Left-sided CDH

- Isolated CDH: no associated structural or genetic abnormalities that are diagnosed
before birth

- Gestational age at delivery =35.0 weeks

- Parental written informed consent
Minimum age
35 Weeks
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Right-sided or bilateral CDH

- Gestational age at delivery <35.0 weeks

- Maternal contraindications: anterior placenta praevia, placental abruption

- High urgency caesarean section, with intended interval to delivery <15 min

- Cases that have been treated during pregnancy with experimental drug therapy aiming to
decrease the occurrence of pulmonary hypertension

- Twin pregnancies in which the infant diagnosed with a CDH is born first

- Multiple birth >2 (triplets or higher order)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Germany
State/province [3] 0 0
Bonn
Country [4] 0 0
Germany
State/province [4] 0 0
Mannheim
Country [5] 0 0
Italy
State/province [5] 0 0
Rome
Country [6] 0 0
Netherlands
State/province [6] 0 0
Nijmegen
Country [7] 0 0
Netherlands
State/province [7] 0 0
Rotterdam
Country [8] 0 0
Sweden
State/province [8] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Other
Name
Erasmus Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Pulmonary hypertension is a major determinant of postnatal survival in infants with a
congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation
period in infants born with this rare birth defect might contribute to the development of
pulmonary hypertension after birth - in particular umbilical cord clamping before lung
aeration. An ovine model of diaphragmatic hernia demonstrated that cord clamping after lung
aeration, called physiological-based cord clamping (PBCC), avoided the initial high pressures
in the lung vasculature while maintaining adequate blood flow, thereby avoiding vascular
remodelling and aggravation of pulmonary hypertension. The investigators aim to investigate
if the implementation of PBCC in the perinatal stabilisation period of infants born with a
CDH could reduce the incidence of pulmonary hypertension in the first 24 hours after birth.

The investigators will perform a multicentre, randomised controlled trial in infants with an
isolated CDH. Before birth, infants will be randomised to either PBCC or immediate cord
clamping, stratified by treatment centre and severity of pulmonary hypoplasia on antenatal
ultrasound. For performing PBCC a purpose-designed resuscitation module (the Concord Birth
Trolley) will be used.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04373902
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Philip LJ DeKoninck, Dr.
Address 0 0
Country 0 0
Phone 0 0
0031107036614
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04373902