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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04373902
Registration number
NCT04373902
Ethics application status
Date submitted
14/04/2020
Date registered
5/05/2020
Titles & IDs
Public title
Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia
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Scientific title
Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial
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Secondary ID [1]
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NL7853
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Secondary ID [2]
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PinC trial
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Universal Trial Number (UTN)
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Trial acronym
PinC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hernias, Diaphragmatic, Congenital
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Hernia; Diaphragm Defect, Congenital
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Pulmonary Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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'
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
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Assessment method [1]
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Pulmonary hypertension is present if at least 2 of the following 4 criteria are present or if the infant requires extracorporeal membrane oxygenation (ECMO) in the first 24 hours after birth:
1. Right ventricular systolic pressure (RVSP) =2/3 systemic systolic pressure\*
2. Right ventricle (RV) dilatation/septal displacement or RV dysfunction +/- left ventricle (LV) dysfunction\*
3. Pre-post ductal SpO2 difference \>10% for at least 15 consecutive minutes
4. Oxygenation Index \>20\*\* \*as found on first ultrasound in first 24 hours after birth; \*\*highest value measured in first 24 hours after birth
The following echocardiographic parameters will be collected to objectify these criteria:
* RV size
* Pulmonary artery acceleration time (PAAT), right ventricular ejection time (RVET), PAAT:RVET ratio
* Intraventricular septum configuration
* LV systolic eccentricity index
* Mean airway pressure
* PaO2
* FiO2
* Preductal+postductal SpO2
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Timepoint [1]
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First 24 hours after birth
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Secondary outcome [1]
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Neonatal: mortality before discharge from the tertiary care hospital
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Assessment method [1]
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Number of patients that died before discharge
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Timepoint [1]
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From birth till discharge from the tertiary care hospital, through study completion an average of one year
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Secondary outcome [2]
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Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
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Assessment method [2]
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Number of patients with 3 or more criteria or ECMO
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Timepoint [2]
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The first 24 hours after delivery
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Secondary outcome [3]
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Neonatal: number of patients requiring ECMO therapy
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Assessment method [3]
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Number of patients requiring ECMO therapy
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Timepoint [3]
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From admission to the ICU until the date of death or the date of discharge home, whichever came first
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Secondary outcome [4]
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Neonatal: number of days of duration of supplemental oxygen need
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Assessment method [4]
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Number of days of duration of supplemental oxygen need
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Timepoint [4]
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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
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Secondary outcome [5]
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Neonatal: number of days of duration of mechanical ventilation
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Assessment method [5]
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Number of days of duration of mechanical ventilation
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Timepoint [5]
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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
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Secondary outcome [6]
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Neonatal: duration of admission to the tertiary care hospital
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Assessment method [6]
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Number of days of admission to the tertiary care hospital
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Timepoint [6]
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From admission to the ICU until the date of discharge to another ward or home, whichever came first
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Secondary outcome [7]
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Maternal: number of patients with postpartum haemorrhage
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Assessment method [7]
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Postpartum haemorrhage is defined as estimated blood loss \>1000 mL
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Timepoint [7]
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The first 24 hours after delivery
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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
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Minimum age
35
Weeks
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/05/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2024
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Actual
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Sample size
Target
140
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash University - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Graz
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Country [2]
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Belgium
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State/province [2]
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Leuven
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Country [3]
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Germany
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State/province [3]
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Bonn
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Country [4]
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Germany
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State/province [4]
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Mannheim
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Country [5]
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Italy
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State/province [5]
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Rome
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Country [6]
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Netherlands
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State/province [6]
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Nijmegen
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Country [7]
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Netherlands
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State/province [7]
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Rotterdam
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Country [8]
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Sweden
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State/province [8]
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Stockholm
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Funding & Sponsors
Primary sponsor type
Other
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Name
Erasmus Medical Center
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04373902
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Trial related presentations / publications
Horn-Oudshoorn EJJ, Knol R, Vermeulen MJ, Te Pas AB, Hooper SB, Cochius-den Otter SCM, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Reiss IKM, DeKoninck PLJ. Physiological-based cord clamping versus immediate cord clamping for infants born with a congenital diaphragmatic hernia (PinC): study protocol for a multicentre, randomised controlled trial. BMJ Open. 2022 Mar 18;12(3):e054808. doi: 10.1136/bmjopen-2021-054808.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Philip LJ DeKoninck, Dr.
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Address
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Country
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Phone
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0031107036614
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04373902