Early regular versus late selective poractant treatment in preterm infants born between 25 and 30 gestational weeks: a prospective randomized multicenter study

J Matern Fetal Neonatal Med. 2014 Mar;27(4):411-5. doi: 10.3109/14767058.2013.818120. Epub 2013 Jul 30.

Abstract

Objective: Surfactant treatment in the early hours of life significantly decreases the rates of death and air leak, and increases survival without bronchopulmonary dysplasia (BPD) in preterm infants. We aimed to compare the impact of early surfactant (ES) administration to late selective (LS) treatment on neonatal outcomes in preterm infants.

Methods: All preterm infants between 25 and 30 wks gestational age and who were not entubated in the delivery room and did not have any major congenital malformation or perinatal asphyxia were randomized to ES treatment (200 mg/kg Curosurf® administration in 1 hour after birth) or LS treatment (200 mg/kg Curosurf®administration in the first 6 h of life if needed). The patients were treated by nasal continuous positive airway pressure (nCPAP) treatment regardless of the surfactant requirement. Outcomes were the necessity of mechanical ventilation, nCPAP duration, the oxygen requirement duration, the rates of BPD, retinopathy of prematurity (ROP) and mortality, and the assessment of the following situations; (pneumothorax, patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC), and intraventricular hemorrhage (IVH) ≥ grade III).

Results: Among 159 infants enrolled in the study, 79 were randomized to ES and 80 to LS treatment groups. Thirty-five patients (44%) in the LS treatment group needed surfactant administration. Necessity of second dose surfactant administration was 8.9% in the ES treatment group. Although necessity of mechanical ventilation, nCPAP duration, oxygen need duration, rates of PDA, NEC, BPD, ROP stage >3 and mortality did not show a significant difference between groups, the ES treatment group had lower rates of pneumothorax and IVH ≥ grade III when compared to the LS treatment group.

Conclusions: ES treatment decreases IVH (≥ grade III) and pneumothorax rates but does not have any effect on BPD when compared to LS.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Biological Products / administration & dosage*
  • Biological Products / therapeutic use
  • Bronchopulmonary Dysplasia / mortality
  • Bronchopulmonary Dysplasia / prevention & control*
  • Bronchopulmonary Dysplasia / therapy
  • Combined Modality Therapy
  • Drug Administration Schedule
  • Female
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Intracranial Hemorrhages / prevention & control
  • Male
  • Phospholipids / administration & dosage*
  • Phospholipids / therapeutic use
  • Pneumothorax / prevention & control
  • Prospective Studies
  • Pulmonary Surfactants / administration & dosage*
  • Pulmonary Surfactants / therapeutic use
  • Respiration, Artificial
  • Retinopathy of Prematurity / prevention & control
  • Treatment Outcome

Substances

  • Biological Products
  • Phospholipids
  • Pulmonary Surfactants
  • poractant alfa