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Phase 4 N=61 Randomized Treatment

Randomized Controlled Trial of Surfactant Delivery Via Laryngeal Mask Airway (LMA) Versus Endotracheal Intubation

Respiratory Distress Syndrome, Newborn

Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant). — 23; 9 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Endotracheal tube insertion (Device); Laryngeal mask airway insertion (Device)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Albany Medical College
Primary completion
Sep 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Rate of Failure of Surfactant Therapy, Either Early (Need for Mechanical Ventilation Within 1 Hour), or Late (FiO2 > 0.60 to Maintain Target SpO2, or Second Dose of Surfactant Within 8 Hours, or Needing More Than 2 Doses of Surfactant).
23; 9
SECONDARY
Number of Surfactant Doses
1.3; 1.8
SECONDARY
Days on Assisted Ventilation
11; 8.5
SECONDARY
Days on Supplemental Oxygen
10; 7.5
SECONDARY
Rate of Pneumothorax
13; 20
SECONDARY
Rate of BPD (O2 Dependence at the Later of 28 Days of Age or 36 Weeks Postmenstrual Age)
7; 10
SECONDARY
Complications During Insertion of LMA
0; 0
SECONDARY
Mortality Rate
0; 0

Summary

In this study, newborn babies with respiratory distress syndrome (RDS), receiving oxygen via nasal CPAP, and needing surfactant treatment will be randomized to standard delivery of surfactant via and endotracheal tube airway(inserted after pre-medication for pain), or to surfactant delivery via laryngeal mask airway (LMA). The intent is to remove the airways and return babies to nasal CPAP, 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 CPAP (needs mechanical ventilation) or, b) late, if the baby requires 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 with standard surfactant treatment following sedation and endotracheal intubation.

Eligibility Criteria

Inclusion Criteria

  • Mild-to-moderate RDS
  • Postnatal age 4 to 48 hours
  • Gestational age 29 0/7 to 36 6/7 weeks
  • Treated with nasal CPAP ≥ 5 cm H2O and FiO2 between 0.30 and 0.60 for at least 2 hours to maintain SpO2 88-95%
  • Informed consent

Exclusion Criteria

  • Weight < 1000 g
  • Airway anomalies
  • Pulmonary air leaks
  • Craniofacial or cardiothoracic malformations
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01042600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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