Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicentre Randomised Controlled Trial of Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on Continuous Positive Airways Pressure
Brief Summary: Trial question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via a minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of mechanical respiratory support, and a higher incidence of survival without bronchopulmonary dysplasia. Trial design: Multicentre, randomised, masked, controlled trial in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory distress, with an FiO2 of \>=0.3 and CPAP pressure 5-8. Infants randomised to surfactant treatment receive 200 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls continue on CPAP. The intervention is masked from the clinical team. Care thereafter is as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome is incidence of death or BPD. Secondary outcomes include incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years. The sample size is 303/group, allowing detection of a 33% difference in the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 5 years in multiple centres internationally.


Options:
A: Inclusion Criteria:

* Gestational age 25-28 completed weeks
* Requiring CPAP or non-invasive positive pressure ventilation with signs of early respiratory distress.
* CPAP pressure of 5-8 cm H2O and FiO2 \>=0.30.
* Less than 6 hours of age.
* Agreement of the Treating Physician in charge of the infant's care.
* Signed parental consent.

Exclusion Criteria:

* Previously intubated, or in imminent need of intubation
* Congenital anomaly or condition that might adversely affect breathing.
* Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia).
* Lack of availability of an OPTIMIST treatment team.
B: Inclusion Criteria:

Infants likely to be delivered to women presenting to a participating Vermont Oxford Network Center at high risk of premature delivery at gestational age 26 + 0 to 29 + 6 weeks will be eligible for inclusion. Specific inclusion criteria that must be met prior to randomization include:

1. Imminent delivery
2. No potentially life-threatening congenital anomaly or genetic syndrome
3. No known lung maturity
4. Antenatal steroid status known
5. Written, informed consent obtained (on admission or prior to delivery).

Exclusion Criteria:

1. Stillborn (Apgar score of 0 at one minute of age)
2. Noted to have a potentially life-threatening congenital anomaly or genetic syndrome noted immediately after delivery.
C: Inclusion Criteria:

* Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to 27 6/7ths) by best obstetrical estimate
* Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation
* Infants whose parents/legal guardians have provided consent for enrollment, or
* Infants without known major congenital malformations

Exclusion Criteria:

* Any infant transported to the center after delivery
* Infants whose parents/legal guardians refuse consent
* Infants born during a time when the research apparatus/study personnel are not available
* Infants \< 24 weeks 0 days or \> 28 weeks 0 days, completed weeks of gestation
D: Inclusion Criteria:

- Gestational age 26-32 weeks

The criteria for failure were met by at least 1 of the following:

* pH: 7.10 and PaCO2: 70 mm Hg
* Recurrent apnea with \>3 episodes (Prophylactic caffeine were used in all infants)
* Single episode of apnea that required bag-and-mask ventilation
* PaO2: 50 mmHg with a fraction of inspired oxygen of \>0.5.

Exclusion Criteria:

* Major congenital anomalies
* Presence of cardiovascular instability
* Intubation at admission to the NICU
* Consent not provided or refused

Answer: A