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Background: One major limitation for less invasive surfactant administration (LISA) is the difficulty in providing sedation before this procedure and the competitive risk of respiratory depression versus avoidance of intubation for most sedative or analgesic drugs used in this context. The objective of this study is to compare the need for mechanical ventilation within 72 h of life following premedication with propofol, versus placebo (rescue with ketamine), for the LISA procedure in preterm neonates born before 32 weeks gestational age (wGA).Methods: ProLISA is a phase III, non-inferiority, multicenter, double blind, randomized, placebo controlled trial designed according to the SPIRIT Statement. Neonates born before 32 wGA in 12 geographically dispersed Neonatal Intensive Care Units in France needing surfactant will be included from September 2019 to September 2022. A sample of 542 patients is needed. The neonate is randomized to the intervention (propofol) or control placebo group. Open label rescue treatment with ketamine is possible in both groups if FANS (Faceless Acute Neonatal pain Scale) is ≥6. To guide drug administration, FANS is scored before attempting laryngoscopy. Once an adequate score has been obtained, LISA is performed according to a standardized protocol. The primary outcome is the need for mechanical ventilation within 72 h of life. Secondary outcomes are tolerance of the procedure, pain evaluation, hemodynamic and neurologic parameters after the intervention, morbidities before discharge and neurodevelopmental assessment at 2 years of age.Discussion: This paper describes the first multicenter, double-blind, randomized, placebo-controlled trial on this topic and will provide crucial information to support implementation of the LISA procedure.Trial Registration: ClinicalTrials.gov: NCT04016246. Registered 06 June 2019, N°EUDRACT: 2018-002876-41. [ABSTRACT FROM AUTHOR]

Background Premedication before neonatal intubation is heterogeneous and contentious. The combination of a short acting, rapid onset opioid with a muscle relaxant is considered suitable by many experts. The purpose of this study was to describe the tolerance and conditions of intubation following anaesthesia with atropine, sufentanil and atracurium in very premature infants. Methods Monocentric, prospective observational study in premature infants born before 32 weeks of gestational age, hospitalised in the NICU and requiring semi-urgent or elective intubation. Intubation conditions, heart rate, pulse oxymetry (SpO2), arterial blood pressure and transcutaneous PCO2 (TcPCO2) were collected in real time during 30 minutes following the first drug injection. Repeated physiological measurements were analysed using mixed linear models. Results Thirty five intubations were performed in 24 infants with a median post conceptional age of 27.6 weeks and a median weight of 850 g at the time of intubation. The first attempt was successful in 74% and was similar for junior (75%) and senior (74%) operators. The operator rated conditions as "excellent" or "good" in 94% of intubations. A persistent increase in TcPCO2 as compared to baseline was observed whereas other vital parameters showed no significant variations 5, 10, 15 and 30 minutes after the first drug injection. Eighteen (51%) desaturations (SpO2 less than or equal to 80% for more than 60 seconds) and 2 (6%) bradycardia (heart rate less than 100 bpm for more than 60 seconds) were observed. Conclusion This drug combination offers satisfactory success rate for first attempt and intubation conditions for the operator without any significant change in heart rate and blood pressure for the patient. However it is associated with frequent desaturations and a possible persistent hypercapnia. SpO2 and PCO2 can be significantly modified during neonatal intubation and should be cautiously followed in this high-risk population. [ABSTRACT FROM AUTHOR]

Background: During the first weeks of hospitalization, premature babies and their parents encounter difficulties in establishing early bonds and interactions. Only a few studies have explored what caregivers can do to meet parents' needs in relation to these interactions and help optimize them. This study sought to explore parents' perception of these first interactions and to identify the actions of caregivers that help or hinder its development. Methods: Prospective study, qualitative discourse analysis of 60 face-to-face interviews conducted with 30 mothers and 30 fathers of infants born before 32 weeks of gestation (mean ± SD: 27 ± 2 weeks of gestational age), during their child's stay in one out of three NICUs in France. Interviews explored parental experience, from before birth up to the first month of life. Results: Data analysis uncovered two main themes, which were independent of parents' geographical or cultural origin but differed between mothers and fathers. First, fathers described the bond with their child as composed more of words and looks and involving distance, while mothers experienced the bond more physically. Secondly, two aspects of the caregivers' influence were decisive: nurses' caring attitude towards baby and parents, and their communication with parents, which reduced stress and made interactions with the baby possible. This communication appeared to be the locus of a supportive and fulfilling encounter between parents and caregivers that reinforced parents' perception of a developing bond. Conclusions: At birth and during the first weeks in the NICU, the creation of a bond between mothers and fathers and their premature baby is rooted in their relationship with the caregivers. Nurses' caring attitude and regular communication adapted to specific needs are perceived by parents as necessary preconditions for parents' interaction and development of a bond with their baby. These results might allow NICU staff to provide better support to parents and facilitate the emergence of a feeling of parenthood. [ABSTRACT FROM AUTHOR]