Physiological-based cord clamping for infants with congenital diaphragmatic hernia: a multicentre randomised controlled trial

Physiological-based cord clamping for infants with congenital diaphragmatic hernia: a multicentre randomised controlled trial - PBCC in CDH (PinC study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54953

Enrollment

110

Registered

2019-06-05

Start date

2020-05-11

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital diaphragmatic hernia

Interventions

Physiological-based cord clamping (PBCC). For PBCC a new specially designed resuscitation table (the Concord) will be used. The table is fully equipped to perform everything that is needed for stabi

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

Inclusion criteria: - Fetus/infant diagnosed with left sided CDH - Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth - Gestational age at delivery >35wks

Exclusion criteria

Exclusion criteria: - Right sided or bilateral CDH - Major associated anomalies (structural and/or genetic) - Maternal contraindications of PBCC: anterior placenta praevia, placental abruption - High urgency caesarean section, with intended interval to delivery less than 15 min - Cases that have undergone antenatal experimental medical therapy aiming to decrease the occurrence of pulmonary hypertension (such as sildenafil) - A twin pregnancy with one of the fetuses diagnosed with CDH infant and that infant is first born either vaginally or via caesarean section - Multiple birth > 2 (triplets or higher order)

Design outcomes

Primary

Measure	Time frame
Pulmonary hypertension diagnosed in the first 24hrs after birth via echocardiography.	—

Secondary

Measure	Time frame
Treatment related - Treatment failure defined as abortion of prescribed procedure and reasons why - Time point of cord clamping Neonatal - Ventilator settings and circulatory support in first 72hrs - Pulmonary hypertension: at 3 days of life and at discharge - Use of inhaled nitric oxide (iNO) and the response to treatment - Response to iNO treatment defined as follows: a decline of 10-20% in the pre-postductal saturation difference, or an increase of 10-20% of PaO2, or improvement in hemodynamic parameters meaning a 10% increase in mean blood pressure, or a decrease in lactate levels - Use of pulmonary vasodilators, such as sildenafil or prostaglandin E - Cerebral oxygenation evaluated continuously with Near-infrared Spectroscopy (NIRS) during the first 24 hours - Broncho Pulmonary Dysplasia (oxygen dependence for at least 28 postnatal days) - Need for extracorporeal membrane oxygenation (ECMO) - Sepsis - Intraventricular haemorrhage - Number of days in intensive care unit - Number of days ventilatory support (mechanical ventilation, CPAP, optiflow) - Survival at discharge - Oxygen dependency at discharge Maternal - Estimated blood loss at time of delivery (mL) - Surgical site infection (caesarean section) - Postpartum haemorrhage > 1000mL	—

Measure

Time frame

Treatment related - Treatment failure defined as abortion of prescribed procedure and reasons why - Time point of cord clamping Neonatal - Ventilator settings and circulatory support in first 72hrs - Pulmonary hypertension: at 3 days of life and at discharge - Use of inhaled nitric oxide (iNO) and the response to treatment - Response to iNO treatment defined as follows: a decline of 10-20% in the pre-postductal saturation difference, or an increase of 10-20% of PaO2, or improvement in hemodynamic parameters meaning a 10% increase in mean blood pressure, or a decrease in lactate levels - Use of pulmonary vasodilators, such as sildenafil or prostaglandin E - Cerebral oxygenation evaluated continuously with Near-infrared Spectroscopy (NIRS) during the first 24 hours - Broncho Pulmonary Dysplasia (oxygen dependence for at least 28 postnatal days) - Need for extracorporeal membrane oxygenation (ECMO) - Sepsis - Intraventricular haemorrhage - Number of days in intensive care unit - Number of days ventilatory support (mechanical ventilation, CPAP, optiflow) - Survival at discharge - Oxygen dependency at discharge Maternal - Estimated blood loss at time of delivery (mL) - Surgical site infection (caesarean section) - Postpartum haemorrhage > 1000mL

—

Countries

Australia, Austria, Belgium, Germany, Italy, Netherlands, Sweden

Contacts

Public ContactE.J.J. Horn-Oudshoorn

Erasmus MC, Universitair Medisch Centrum Rotterdam

pinc@erasmusmc.nl010 703 66 14

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026