Comparison of "IN-REC-SUR-E" and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial).

BACKGROUND: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. METHODS: In this study, 382 infants born at 24+0-27+6 weeks' gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks' postmenstrual age. The secondary outcomes are BPD at 36 weeks' postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24+0 to 25+6 weeks or 26+0 to 27+6 weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). DISCUSSION: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24+0-27+6 weeks' gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks' postmenstrual age of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.

Neonatal outcomes and long-term neurodevelopmental evaluations of hospitalized early term infants: prospective case-control study.

BACKGROUNDS: It was intended to compare early term babies to term babies by reviewing short-term issues and long-term neurodevelopmental evaluations. METHODS: It was planned as a prospective case-control study. Of the 4263 infants admitted to the neonatal intensive care unit, 109 infants born at early term by elective cesarean section and hospitalized within the first 10 postnatal days were included in the study. As the control group, 109 babies born at term were enrolled. Nutrition status of infants, reasons for hospitalization in the first postnatal week were recorded. When the babies were 18-24 months old, an appointment was made for neurodevelopmental evaluation. RESULTS: In the early term group, the time of breastfeeding was later than the control group, with a statistically significant difference. Similarly, breastfeeding difficulty, need for formula in the first week postpartum and hospitalization were found to be significantly higher in the early term group. Considering the short-term results; pathological weight loss, hyperbilirubinemia requiring phototherapy and feeding difficulties were statistically significantly higher in the early term group. Neurodevelopmental delay did not statistically differ across the groups, but the early term group's MDI and PDI scores were found to be statistically lower than those of the term group. CONCLUSION: Early term infants are thought to be like term infants in many ways. Although these babies are similar to term babies, they are still physiologically immature. The short and long-term negative consequences of early term birth are obvious, non-medical elective early term births should be prevented.