Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
Brief Summary: The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.

Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.

The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?


Options:
A: Inclusion Criteria:

* birthweight 500 to 1250 grams
* postnatal age day 1 to day 10
* infant considered a candidate for methylxanthine therapy by clinical staff

Exclusion Criteria:

* dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
* unlikely to comply with long-term follow-up
* prior treatment with a methylxanthine
B: Inclusion Criteria:

* All inborn VLBW infants (birthweight less than 1500 g and Gestational Age \< 32 wks) with signs of RDS, spontaneously breathing and only supported by N-CPAP, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies.

Exclusion Criteria:

* Apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth
* Newborns with genetic disease and/or with major congenital malformations
* Newborns for whom it was not obtained informed consent within two hours from birth
C: Inclusion Criteria:

* Birth weight \<1000 gm
* Gestational age \<30 completed weeks
* Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:

  * the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
  * the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.

Exclusion Criteria:

* Considered non-viable by clinician (decision not to administer effective therapies)
* Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
* Infants known to require surgical treatment
* Abnormalities of the upper and lower airways
* Neuromuscular disorders
* Infants who are \>28 days old and continue to require mechanical ventilation with an endotracheal tube
D: Inclusion Criteria:

* Preterm with a weight less than 1501 g
* Gestational age less or equal to 34 weeks
* Preterm that meets extubation criteria after at least 2 hours and less than 14 days connected to mechanical ventilation
* Patient receiving methylxanthynes

Exclusion Criteria:

* Patient more than 14 days in mechanical ventilation
* Newborn with congenital cardiopathy
* Newborn with congenital malformation
* Newborn wirh chromosomopathy or genopathic disease
* Newborn with suspected gastrointestinal disease
* Newborn with neuromuscular disease or receiving muscle relaxants
* Lack or informed consent signed by parents or legal representative

Answer: C