Please select the eligibility criteria that correspond to the clinical trial below.
Title: Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
Brief Summary: Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel.

OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7 days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.

STUDY DESIGN, SETTING AND POPULATION A single-centre randomized clinical trial will be conducted at Mulago National Referral Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines.

UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.


Options:
A: 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)
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:

* 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:

* 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

Answer: A