Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation (INSURE Technique) Versus Laryngeal Mask Airway (LMA) for Respiratory Distress Syndrome (RDS) in Preterm Neonates
Brief Summary: In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal continuous airway pressure (CPAP) modalities, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway (inserted after pre-medication for pain with a short-acting narcotic), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to non-invasive CPAP support, after surfactant is given. The primary outcome measure is the rate of failure of initial surfactant therapy. Standardized failure criteria are reached: a) early, if the baby is unable to be placed back on non-invasive CPAP (i.e., needs tracheal intubation and mechanical ventilation) or, b) late, if the baby requires ventilation, retreatment with surfactant within 8 hours or more than 2 doses of surfactant.

The objective of this protocol is to reduce the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS needing rescue surfactant therapy by instilling surfactant though an LMA, while achieving comparable efficacy of surfactant treatment.

The hypothesis is that surfactant treatment through an LMA will decrease the proportion of babies with RDS who require mechanical ventilation or subsequent intubation, when compared to standard surfactant treatment following endotracheal intubation with sedation.


Options:
A: 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
B: 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).
C: Inclusion Criteria:

* Mild-to-moderate RDS;
* Postnatal age 2 to 48 hours;
* Gestational age 27 0/7 to 36 6/7 weeks;
* Treated with nasal CPAP modalities ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain SpO2 90-95%;
* Informed consent

Exclusion Criteria:

* Weight \< 800 g;
* Airway anomalies;
* Pulmonary air leaks;
* Craniofacial or cardiothoracic malformations
D: 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)

Answer: C