Respiratory effect of the LISA (Less Invasive surfactant administration) method with sedation by propofol versus absence of sedation: Double-blind comparative randomized clinical trial

Conditions

Respiratory Distress Syndrome of preterm babies born < 32 weeks of gestational age

Brief summary

Rate of MV from the start of the LISA procedure up to 72 hours of life in each group.

Detailed description

Rate of MV from the start of the LISA procedure up to 72 hours of life in each class of GA (<28, 28-31wGA), Faceless Acute Neonatal Scale (FANS) assessed during the LISA: this scale evaluates behavioral items (limb movements, vocal expression) and physiological items (heart rate variation, bradycardia or desaturation), on a scale from 0 (no pain) to 10 (maximal pain)., Rate of ketamine administration for rescue: This administration will be indicated after two (< 28 wGA) or 3 (28 – 31 wGA) administrations of the drug, if adequate comfort is not achieved (FANS≥6 or baby not comfortable), Quality conditions, To assess BPD at 36wGA, In-hospital neonatal morbidity and mortality, At two years : ASQ questionnaire, Gross Motor Function Classification Scale in cases of motor impairment, Visual and hearing function

Related papers

No related papers found yet.

Interventions

DRUGPROPOFOL LIPURO 1 % (10 mg/ml)

DRUGémulsion injectable ou pour perfusion

DRUGMEDIALIPIDE 20 POUR CENT

DRUGémulsion pour perfusion

DRUGKETAMINE RENAUDIN 10 mg/ml

DRUGsolution injectable

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Rate of MV from the start of the LISA procedure up to 72 hours of life in each group.	—

Secondary

Measure	Time frame
Rate of MV from the start of the LISA procedure up to 72 hours of life in each class of GA (<28, 28-31wGA), Faceless Acute Neonatal Scale (FANS) assessed during the LISA: this scale evaluates behavioral items (limb movements, vocal expression) and physiological items (heart rate variation, bradycardia or desaturation), on a scale from 0 (no pain) to 10 (maximal pain)., Rate of ketamine administration for rescue: This administration will be indicated after two (< 28 wGA) or 3 (28 – 31 wGA) administrations of the drug, if adequate comfort is not achieved (FANS≥6 or baby not comfortable), Quality conditions, To assess BPD at 36wGA, In-hospital neonatal morbidity and mortality, At two years : ASQ questionnaire, Gross Motor Function Classification Scale in cases of motor impairment, Visual and hearing function	—

Measure

Time frame

Rate of MV from the start of the LISA procedure up to 72 hours of life in each class of GA (<28, 28-31wGA), Faceless Acute Neonatal Scale (FANS) assessed during the LISA: this scale evaluates behavioral items (limb movements, vocal expression) and physiological items (heart rate variation, bradycardia or desaturation), on a scale from 0 (no pain) to 10 (maximal pain)., Rate of ketamine administration for rescue: This administration will be indicated after two (< 28 wGA) or 3 (28 – 31 wGA) administrations of the drug, if adequate comfort is not achieved (FANS≥6 or baby not comfortable), Quality conditions, To assess BPD at 36wGA, In-hospital neonatal morbidity and mortality, At two years : ASQ questionnaire, Gross Motor Function Classification Scale in cases of motor impairment, Visual and hearing function

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Countries

France

Outcome results

None listed