Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

Pulmonary Hypertension Clinical Trial

— PinC  

Official title:

Physiological-based Cord Clamping Versus Immediate Cord Clamping for Infants Born With Congenital Diaphragmatic Hernia: a Multicentre, Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04373902
• Other study ID #: PinC trial
• Secondary ID: NL7853
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: Erasmus Medical Center
• Contact: Philip LJ DeKoninck, Dr.
• Phone: 0031107036614
• Email: p.dekoninck[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Congenital Abnormalities
• Hernia
• Hernia, Diaphragmatic
• Hernia; Diaphragm Defect, Congenital
• Hernias, Diaphragmatic, Congenital
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Procedure:
• Physiological-based cord clamping
See 'Arm'

Locations

Country	Name	City	State
Australia	Monash University	Melbourne
Austria	Medical University Graz	Graz
Belgium	University Hospitals leuven	Leuven
Germany	Universitätskrankenhaus Bonn	Bonn
Germany	Universitätsklinik Mannheim	Mannheim
Italy	Ospedale Pediatrico Bambino Gesu	Rome
Netherlands	Radboudumc University Medical Center	Nijmegen
Netherlands	Erasmus MC University Medical Center - Sophia Children's Hospital	Rotterdam
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First 24 hours after birth
Secondary	Neonatal: mortality before discharge from the tertiary care hospital	Number of patients that died before discharge	From birth till discharge from the tertiary care hospital, through study completion an average of one year
Secondary	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	The first 24 hours after delivery
Secondary	Neonatal: number of patients requiring ECMO therapy	Number of patients requiring ECMO therapy	From admission to the ICU until the date of death or the date of discharge home, whichever came first
Secondary	Neonatal: number of days of duration of supplemental oxygen need	Number of days of duration of supplemental oxygen need	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	Neonatal: number of days of duration of mechanical ventilation	Number of days of duration of mechanical ventilation	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	Neonatal: duration of admission to the tertiary care hospital	Number of days of admission to the tertiary care hospital	From admission to the ICU until the date of discharge to another ward or home, whichever came first
Secondary	Maternal: number of patients with postpartum haemorrhage	Postpartum haemorrhage is defined as estimated blood loss >1000 mL	The first 24 hours after delivery