Please select the eligibility criteria that correspond to the clinical trial below.
Title: Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method with Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.
Brief Summary: The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.


Options:
A: 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.
B: Inclusion Criteria:

* Preterm Infants \< 32 wGA (weeks of gestational age)
* Presenting a RDS (respiratory distress syndrome)

  * in the first 48 hours of life
  * treated by CPAP (continuous positive airway pressure) or BiPAP (Bilevel Positive Airway Pressure)
  * requiring surfactant :

    * FIO2 : (fraction of inspired oxygen)

      * if 28 - 31 SA : FiO2 ≥30% for a duration ≥ 10mn
      * if \<28 SA FIO2 ≥25% for a duration ≥10mn
    * SpO2 (arterial oxygen saturation) : to obtain a SpO2 between ≥88 and ≤ 95%
* Available IntraVenous line (peripheral, umbilical or central catheter)
* Recipient of the French Social Security
* Informed consent form signed

Exclusion Criteria:

* Congenital and/or major malformations
* FIO2 \>60%
* Silverman score \>6
* Contraindication to the use of Propofol :
* Low Blood Pressure with 2 successive measurements (Mean \< Gestational Age expressed in Weeks of Gestation) persisting after one volume expansion,
* Use of inotropic medication to maintain a normal blood pressure.
* Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the previous 24h
* Coma, convulsions, areactivity at neurological examination
C: 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.
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: B