Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of Surfactant Administration by Laryngeal Mask Airway (LMA)
Brief Summary: In this protocol we will conduct a randomized controlled trial where babies with respiratory distress syndrome (RDS) who have not yet reached criteria for intubation, will be randomized to receive surfactant by LMA or to continue receiving standard therapy of nasal CPAP and supplemental oxygen. All babies will be given surfactant by endotracheal tube if they reach "failure" criteria, which is the standard criterion for surfactant administration (i.e., FiO2= 65% while receiving nasal CPAP).

The objective of this RCT is to determine if surfactant can be successfully administered by LMA, thus perhaps avoiding the need for endotracheal intubation. The hypothesis is that fewer babies in the LMA group would reach failure criteria.


Options:
A: Inclusion Criteria:

* Birthweight \> 1200 grams
* Chronologic age \< 72 hours.
* Diagnosis of RDS by clinical and radiographic criteria.
* Treated with nasal CPAP and supplemental oxygen \> 30% and not requiring \> 60% FiO2 for longer than 30 minutes to maintain SaO2 88-95%.
* Parental consent.

Exclusion Criteria:

* Birthweight \< 1200 gms.
* Diagnosis other than RDS (e.g., meconium aspiration syndrome).
* Babies who require or have already had endotracheal intubation.
* Babies with congenital anomalies or conditions thought by the attending physician to contribute to respiratory symptoms and/or to restrict adequate spontaneous breathing (e.g., congenital heart disease, obtundation from maternal drugs, certain airway malformations, diaphragmatic hernia).
B: Inclusion Criteria:

* Gestational age at time of enrollment 28 0/7 to 35 6/7 weeks postmenstrual age
* Age less than or equal to 36 hours old
* On nCPAP 6 with supplemental oxygen requirement (Fi02 greater than or equal to 30%) for greater than or equal to 30 minutes (to maintain Sa02 between 88-92%)
* Chest radiograph and clinical presentation consistent with respiratory distress syndrome (tachypnea, retractions, nasal flaring, and/or grunting

Exclusion Criteria:

* Prior mechanical ventilation or surfactant administration
* Major congenital anomaly
* Abnormality of the airway
* Respiratory distress secondary to an etiology other than respiratory distress syndrome (pneumothorax, meconium aspiration syndrome, pneumonia, hypoxic-ischemic encephalopathy)
* Apgar score \< 5 at 5 minutes of age
C: Inclusion Criteria:

* Inborn baby (=born in the hospital)
* Expected ≥ 34-week gestation
* Expected birth weight ≥ 2000 g
* Need for PPV at birth
* Parental consent

Exclusion Criteria:

* Major malformations (incompatible with sustained life or affecting the airways)
D: 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

Answer: A