A Randomized Trial Comparing Surfactant Administration Using InSurE Technique and the Minimally Invasive Surfactant Therapy in Preterm Infants (28 to 34 Weeks of Gestation) with Respiratory Distress Syndrome

Abstract

Background: The present study was conducted to investigate and compare the effectiveness of the minimally invasive surfactant therapy (MIST) and the INSURE technique (Intubation, Surfactant administration, and extubation) in spontaneously breathing preterm infants. Methods: Preterm infants (28-34 weeks of gestation) born with respiratory distress syndrome between April 2013 and February 2014 were randomly selected to receive 200 mg/kg of surfactant (Curosurf) using either MIST or INSURE techniques. In the MIST group, surfactant was instilled via a thin tracheal catheter (5-f) that was then removed. In the INSURE group, the infants were first intubated, administered surfactant through passing a feeding tube through the endotracheal tube, and then extubated after 30 seconds of positive pressure ventilation. Nasal CPAP for respiratory support continued in both groups after performing the procedures. The amounts of supplemental oxygen required, intensive care requirements, and outcomes were compared between the two groups. Results: The present study examined 27 infants in the MIST group and 26 in the INSURE group. The amount of oxygen required by

Minimally invasive surfactant therapy versus InSurE in preterm neonates of 28 to 34 weeks with respiratory distress syndrome on non-invasive positive pressure ventilation—a randomized controlled trial

“…Interruption of nCPAP during the procedure was the problem in previous studies; we kept continuous NIPPV support through appropriate nasal interface during the MIST manipulation. It minimised incidence of desaturation, bradycardia and need of manual ventilation here during MIST.There was also 96.5% success rate for the first attempt at introduction of feeding tube in MIST technique in the present study whereas it was reported as 75% in one previous study [23]. High success rate in our study could be due to training of neonatologists in MIST technique prior to recruitment of the study.…”

Efficacy and safety of surfactant administration via thin catheter in preterm infants with neonatal respiratory distress syndrome: A systematic review and meta‐analysis

“…Finally, 35 articles were excluded after reading the full text, and 13 articles [18][19][20][21][22][23][24][25][26][27][28][29][30] were included in the meta-analysis with a total of 1931 infants, including 964 in the intervention group and 967 in the control group.…”

“…All studies described similar criteria for surfactant delivery with similar values of fractional oxygen inhalation (FiO 2 ) and/or respiratory distress severity, whereas 12 articles 18,20-30 described criteria for rescue intubation. Postnatal age at randomization was less than 12 h of life in 11 trials, 18,20,[22][23][24][25][26][27][28][29][30] of which three trials 27,29,30 were less than 6 h, four trials 20,22,23,25 were less than 2 h and one trial 24 was less than 1 h. In ten articles, [18][19][20][21][22][23][24][25]28,30 the type of pulmonary surfactant was Curosurf, whereas other kinds of pulmonary surfactant (Survanta, Neosurf, and Calsurf) were used in three articles. 26,27,29 The application of cesarean sections and antenatal steroids was similar between the two groups in each study.…”

“…Eleven trials 18,20,[22][23][24][25][26][27][28][29][30] reported the method of random sequence generation, and eleven trials [18][19][20]22,[24][25][26][27][28][29][30] described the specific allocation concealment methods. Twelve articles 18,[20][21][22][23][24][25][26][27][28][29][30] reported complete outcome data. For reporting bias, six studies 19,21,23,26,28,30 showed high risk because they were not registered in a public trial registry or their registration date was later than the end date of the trial, and two studies 24,29 showed high risk for other reasons (Table 2).…”

“…Halim et al 26 had a major weight in the meta-analysis for mortality (weight 28.7%) and was likely to have large impact on the result, thus we excluded this article for sensitivity analysis and showed similar results (RR: 0.76, 95% CI: 0.53-1.08, p = .13, I 2 = 18%, 9 studies [18][19][20][21][22][23][24][25]27 [n = 1378]) (Figure S1A). Furthermore, sensitivity analysis restricted to studies that explicitly stated the use of the INSURE protocol in the control group yielded different results (RR: 0.69, 95% CI: 0.51-0.95, p = .02, I 2 = 17%, 8 studies [19][20][21][23][24][25][26][27] [n = 1047]) (Supplemental Figure S1B).…”