Hernias, Diaphragmatic, CongenitalPinCNCT04373902
Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia
A study testing Physiological-based cord clamping in people with Hernias, Diaphragmatic, Congenital and Hernia; Diaphragm Defect, Congenital, run by Erasmus Medical Center at 9 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 weeks and older
- Conditions the study is for
- Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Pulmonary Hypertension
- What is being tested?
- Physiological-based cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 11 May 2020to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Germany2 sites
Universitätskrankenhaus Bonn
Bonn
Universitätsklinik Mannheim
Mannheim
Netherlands2 sites
Radboudumc University Medical Center
Nijmegen
Erasmus MC University Medical Center - Sophia Children's Hospital
Rotterdam
About this study
Official title: Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial
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.
- Conditions
- Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Pulmonary Hypertension
- Being tested
- Physiological-based cord clamping
- Keywords
- Congenital diaphragmatic hernia, Perinatal stabilisation, Resuscitation, Pulmonary hypertension, Birth defect, Physiological-based cord clamping
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Hernia, Diaphragmatic, Hypertension, Pulmonary, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological-based cord clampingProcedure or surgery
See 'Arm'
| Study group | Role | What they receive |
|---|---|---|
| Physiological-based cord clamping | Experimental | 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. Receives: Procedure: Physiological-based cord clamping |
| Immediate cord clamping | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
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:
- Right ventricular systolic pressure (RVSP) ≥2/3 systemic systolic pressure*
- Right ventricle (RV) dilatation/septal displacement or RV dysfunction +/- left ventricle (LV) dysfunction*
- Pre-post ductal SpO2 difference >10% for at least 15 consecutive minutes
- 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
Measured: First 24 hours after birth
Secondary outcomes (7)
Neonatal: mortality before discharge from the tertiary care hospital
Number of patients that died before discharge
Measured: From birth till discharge from the tertiary care hospital, through study completion an average of one year
Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
Number of patients with 3 or more criteria or ECMO
Measured: The first 24 hours after delivery
Neonatal: number of patients requiring ECMO therapy
Number of patients requiring ECMO therapy
Measured: From admission to the ICU until the date of death or the date of discharge home, whichever came first
Neonatal: number of days of duration of supplemental oxygen need
Number of days of duration of supplemental oxygen need
Measured: 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
Neonatal: number of days of duration of mechanical ventilation
Number of days of duration of mechanical ventilation
Measured: 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
Neonatal: duration of admission to the tertiary care hospital
Number of days of admission to the tertiary care hospital
Measured: From admission to the ICU until the date of discharge to another ward or home, whichever came first
Maternal: number of patients with postpartum haemorrhage
Postpartum haemorrhage is defined as estimated blood loss >1000 mL
Measured: The first 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start11 May 2020
- Primary completion1 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hernias, Diaphragmatic, CongenitalStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip L.J. DeKoninck, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373902
- Sponsor's protocol ID
- PinC CDH trial
- Other IDs
- NL7853
- Acronym
- PinC
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Horn-Oudshoorn EJJ, Vermeulen MJ, Knol R, Bout-Rebel R, Te Pas AB, Hooper SB, Otter SCMC, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Capolupo I, Burgos CM, Hansen BE, Reiss IKM, DeKoninck PLJ. Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan. Trials. 2024 Mar 20;25(1):198. doi: 10.1186/s13063-024-08027-7.
PubMed 38509614Horn-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.
PubMed 35304395
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04373902
- Acronym / sponsor ID
- PinC / PinC CDH trial
- Conditions
- Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Pulmonary Hypertension
- Keywords
- Congenital diaphragmatic hernia, Perinatal stabilisation, Resuscitation, Pulmonary hypertension, Birth defect, Physiological-based cord clamping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 5 May 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiological-based cord clamping | Experimental | Procedure: Physiological-based cord clampingIn 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. |
| Immediate cord clamping | No intervention | –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. |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Physiological-based cord clampingSee 'Arm' | Procedure or surgery | Physiological-based cord clamping |
Primary outcome
Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
Time frame: First 24 hours after birth
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
7 secondary outcomes
Neonatal: mortality before discharge from the tertiary care hospital
Time frame: From birth till discharge from the tertiary care hospital, through study completion an average of one year
Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
Time frame: The first 24 hours after delivery
Neonatal: number of patients requiring ECMO therapy
Time frame: From admission to the ICU until the date of death or the date of discharge home, whichever came first
Neonatal: number of days of duration of supplemental oxygen need
Time frame: 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
Neonatal: number of days of duration of mechanical ventilation
Time frame: 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
Neonatal: duration of admission to the tertiary care hospital
Time frame: From admission to the ICU until the date of discharge to another ward or home, whichever came first
Maternal: number of patients with postpartum haemorrhage
Time frame: The first 24 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 38509614Horn-Oudshoorn EJJ, Vermeulen MJ, Knol R, Bout-Rebel R, Te Pas AB, Hooper SB, Otter SCMC, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Capolupo I, Burgos CM, Hansen BE, Reiss IKM, DeKoninck PLJ. Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan. Trials. 2024 Mar 20;25(1):198. doi: 10.1186/s13063-024-08027-7.
- Derived from this study: PubMed 35304395Horn-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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological-based cord clamping in people with Hernias, Diaphragmatic, Congenital and Hernia; Diaphragm Defect, Congenital, run by Erasmus Medical Center at 9 sites in 7 countries.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Netherlands, Australia, Austria, Belgium and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth. (time frame: First 24 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373902, which also lists 2 linked publications.
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 25 Sep 2026.