Here is the design of a clinical trial:

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

Included conditions:
- Hernias, Diaphragmatic, Congenital
- Hernia; Diaphragm Defect, Congenital
- Pulmonary Hypertension

Study Armgroups:
- {'label': 'Physiological-based cord clamping', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Procedure: Physiological-based cord clamping']}
- {'label': 'Immediate cord clamping', 'type': 'NO_INTERVENTION', 'description': '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.'}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Physiological-based cord clamping', 'description': "See 'Arm'", 'armGroupLabels': ['Physiological-based cord clamping']}

Primary Outcomes:
- {'measure': 'Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.', 'description': '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:\n\n1. Right ventricular systolic pressure (RVSP) ≥2/3 systemic systolic pressure\\*\n2. Right ventricle (RV) dilatation/septal displacement or RV dysfunction +/- left ventricle (LV) dysfunction\\*\n3. Pre-post ductal SpO2 difference \\>10% for at least 15 consecutive minutes\n4. Oxygenation Index \\>20\\*\\* \\*as found on first ultrasound in first 24 hours after birth; \\*\\*highest value measured in first 24 hours after birth\n\nThe following echocardiographic parameters will be collected to objectify these criteria:\n\n* RV size\n* Pulmonary artery acceleration time (PAAT), right ventricular ejection time (RVET), PAAT:RVET ratio\n* Intraventricular septum configuration\n* LV systolic eccentricity index\n* Mean airway pressure\n* PaO2\n* FiO2\n* Preductal+postductal SpO2', 'timeFrame': 'First 24 hours after birth'}

Please estimate the sample size based on the assumption: 
80% power, 0.05 significance level, and good overall adherence to the protocol based on previous feasibility studies.
Sample size estimates
        The background incidence of pulmonary hypertension in infants with a CDH can be estimated based on historical cohorts. The largest registry available is the CDH Study Group registry consisting of data from 70 participating centres in 13 countries. A recent review of 3367 patients of this cohort (2007â2014) reports a 69.7% incidence of pulmonary hypertension in the first week after birth (median of 0âdays (0â8)).35 As this is the first human clinical study evaluating PBCC with pulmonary hypertension as primary outcome, we cannot estimate the effect size. Thus, we suggest using a clinically relevant change in incidence of pulmonary hypertension to determine the sample size. We consider that a relative decrease by one-third in the incidence of pulmonary hypertension in the first 24 hours after birth is realistic and is significant enough to influence change in the neonatal management of infants with a CDH. Based on the background incidence of pulmonary hypertension, we calculated that at least 140 infants (70 in each group) are needed to detect a 1/3 reduction, with 80% power and 0.05 significance level. It will be difficult to estimate the number of cases that will have the umbilical cord clamped earlier than the times within the PBCC protocol. However, based on the results from two small human feasibility studies, it can be expected that we will have good overall adherence to the protocol.