Less invasive surfactant administration and complications of preterm birth.
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ABSTRACT:
SUBMITTER: Hartel C
PROVIDER: S-EPMC5974027 | biostudies-literature | 2018 May
REPOSITORIES: biostudies-literature
Publications
Less invasive surfactant administration and complications of preterm birth.
Härtel Christoph C Paul Pia P Hanke Kathrin K Humberg Alexander A Kribs Angela A Mehler Katrin K Vochem Matthias M Wieg Christian C Roll Claudia C Herting Egbert E Göpel Wolfgang W
Scientific reports 20180529 1
In a large cohort study of the German Neonatal Network (GNN) we aimed to evaluate whether less invasive surfactant administration (LISA) strategy is associated with complications of preterm birth. Within the observational period n = 7533 very-low-birth-weight infants (VLBWI) with gestational age 22 0/7 to 28 6/7 weeks were enrolled in GNN; n = 1214 VLBWI never received surfactant, n = 2624 VLBWI were treated according to LISA procedure, n = 3695 VLBWI had surfactant via endotracheal tube (ETT). ...[more]
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Project description:Less invasive surfactant administration (LISA) has been introduced at our tertiary Level IV perinatal center since 2016 with an unsatisfactory success rate, which we attributed to an inconsistent, non-standardized approach and ambiguous patient inclusion criteria. This study aimed to improve the LISA success rate to at least 75% within 12 months by implementing a highly standardized LISA approach combined with team training. The Plan Do Study Act method of quality improvement was used for this initiative. Baseline assessment included a review of patient medical records 12 months before the intervention regarding patient characteristics, method success rate, respiratory, and adverse outcomes. A multi-professional team developed a standardized LISA approach and a training program including an educational film, checklists, pocket cards, and team briefings. Twenty-one preterm infants received LISA before and 24 after the intervention. The mean LISA success rate improved from 62% before the intervention to 92% (p = 0.029) after the intervention. Implementing a highly standardized LISA approach and multi-professional team training significantly improved the methods' success rate.
| S-EPMC8700472 | biostudies-literature
Project description:The aims of this study were to assess the efficacy and feasibility of a new, less invasive surfactant administration technique for beractant replacement using a specifically designed cannula in preterm infants born at <32 weeks of gestation and to compare short- and long-term outcomes between this approach and standard treatment, consisting of intubation, administration of surfactant and early extubation to nasal continuous positive airway pressure.This was a single-center, prospective, open-label, non-randomized, controlled pilot study with an experimental cohort of 30 patients treated with less invasive surfactant administration and a retrospective control group comprising the 30 patients most recently treated with the standard approach. Beractant (4 ml/kg) was administered as an exogenous surfactant in both groups if patients on nasal continuous positive airway pressure during the first three days of life were in need of more than 30% FiO2. Clinicaltrials.gov: NCT02611284.In the group with less invasive surfactant administration, beractant was successfully administered in all patients. Thirteen patients (43.3%) in the group with less invasive surfactant administration required invasive mechanical ventilation for more than 1 hour during the first 3 days of life, compared with 22 (73%) in the control group (p<0.036). The rate of requiring invasive mechanical ventilation for more than 48 hours was similar between the infants in the two groups (46% vs. 40%, respectively). There were no differences in other outcomes.The administration of beractant (4 ml/kg) using a less invasive surfactant administration technique with a specifically designed cannula for administration is feasible. Moreover, early invasive mechanical ventilation exposure is significantly reduced by this method compared with the strategy involving intubation, surfactant administration and early extubation.
| S-EPMC4785853 | biostudies-literature
Project description:BackgroundRespiratory distress syndrome (RDS) is a frequent complication of premature birth. Treating RDS by continuous positive airway pressure and less invasive surfactant administration (LISA) may reduce bronchopulmonary dysplasia. Surfactant, however, can be inactivated by bacterial infection. Therefore, potential routes of microbe transmission into the airway are of interest. The aim of this study was to evaluate microbiological contamination of catheters used for LISA procedures and its association with postnatal age.MethodsCatheter tips used for LISA procedures via the nasal route (LISA-n) in infants with RDS were placed into a sterile eSwab container directly after the procedure, cultured and examined for microbiological contamination.ResultsInterpretable results could be collected from 20 catheter tips. Four showed positive culture results (20%) with microbes potentially associated with the development of early onset neonatal sepsis. Risk of positive microbe detection increased with postnatal age (< 4 h: 10%; 4-18 h: 20%; > 18 h: 40%).ConclusionsIn this pilot study, the risk of tracheal microbe transmission following the LISA-n procedure increased with postnatal age. Although the clinical relevance of this finding is unclear, earlier surfactant administration might reduce the risk of catheter contamination.Trial registration numberSubstudy of the registered Trial: feasibility study - Neofact: NCT04086095, www.ClinicalTrials.gov, September 11, 2019.
| S-EPMC7236511 | biostudies-literature
Project description:OBJECTIVE:There are differences in the adoption rates of less invasive surfactant administration (LISA) worldwide. We aimed to describe and analyze the process of LISA introduction at the country level. METHODS:A standardized training program (33 courses covering >500 neonatologists) was followed by a cohort study. Data regarding consecutive LISA procedures were acquired over 12 months in 31 tertiary neonatal centers, using a dedicated on-line platform. RESULTS:Of 500 LISA procedures, 75% were performed by specialists and 25% by residents. The mean percentage share of LISA in all surfactant therapies was 24%, which represents a 6-fold increase compared to previous years. After 12 months, 76% of the procedures were rated "easy/very easy" vs 59% at baseline (p<0.05). Surfactant re-treatment rate was 15%. Twenty-three percent of infants required mechanical ventilation within 72 hours of life. Oxygen desaturation and surfactant reflux were the most frequent complications. Unlike previous reports describing exclusive use of nasal continuous positive airway pressure (nCPAP) during LISA, majority of procedures (63%) were carried out using nasal intermittent positive pressure ventilation (NIPPV) or Bilevel Positive Airway Pressure (BiPAP). Efficacy of LISA with NIPPV or BiPAP was not significantly different from that with nCPAP (22.4% vs 24.5% of cases requiring intubation). Ventilation was provided with nasal cannulas or nasal masks (90%) and rarely with "RAM" cannulas or nasopharyngeal tubes. Rigid catheters were preferred (88.4%); tracheal insertion was successful at first attempt in 87% of cases. Majority of infants (79%) received no premedication prior to the procedure and almost all were given caffeine citrate. Median time of instillation was 1.5 minutes. CONCLUSIONS:The LISA procedure does not appear to be technically difficult to master. Training combining theory with practical exercises is an efficient implementation strategy. Variations in adoption rates indicate the need for additional, more personalized teachings in some centers.
| S-EPMC7337349 | biostudies-literature
Project description:BackgroundLess invasive surfactant administration (LISA) is a way of giving surfactant without endotracheal intubation and has shown to be promising in reducing the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. However, the mechanism underlying its beneficial effect and variations in the technique of administration may prevent its widespread use. This trial aims to evaluate the effects of two methods of surfactant administration, LISA or endotracheal surfactant administration followed by low peak pressure (LPPSA) ventilation, in preterm infants with respiratory distress syndrome (RDS).MethodsThe LISA Or Low Peak Pressure trial is to be conducted in 14 tertiary neonatal intensive care units in China. A total of 600 preterm infants born with gestational age between 250/7 and 316/7 weeks and with a primary diagnosis of RDS will be involved in the study. Infants will be randomized to the LISA or LPPSA group when surfactant therapy is indicated. Primary outcomes include mortality, severity of bronchopulmonary dysplasia at 36 weeks of postmenstrual age (PMA), and mechanical ventilation (MV) in the first 72 h of life. Secondary outcomes include the days of MV, duration of all sorts of non-invasive respiratory support, fraction of inspired oxygen, oxygen saturation before and after surfactant administration, and time required to perform the procedure for surfactant administration. The incidence of comorbidities, including retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), hemodynamically significant patent ductus arteriosus (hsPDA), pneumothorax, and massive pulmonary hemorrhage within 48 h of surfactant administration, and the failure rates of each technique will be determined.DiscussionData from recent systematic review and meta-analysis have suggested a possible improvement in outcomes of preterm infants with RDS by the LISA technique. However, robust evidence is lacking. Why LISA plays a potential role in reducing respiratory morbidity, mainly BPD in preterm infants, remains unclear. The possible explanations are the active and uninterrupted delivery of continuous positive airway pressure during the LISA procedure and the avoidance of complications caused by intubation and relatively high pressure/volume ventilation following surfactant administration. We hypothesized that LISA's effectiveness lies mainly in avoiding relatively high-pressure positive ventilation immediately following surfactant administration. Thus, this multicenter randomized controlled trial will focus on issues of endotracheal intubation and the pressure/volume used during conventional surfactant administration. The effectiveness, safety and comorbidities of preterm infants following LISA or LPPSA will be evaluated.Trial registrationChinese Clinical Trial Registry: ChiCTR1900020970. Registered on 23 January 2019.
| S-EPMC7289227 | biostudies-literature
Project description:IntroductionRespiratory distress syndrome (RDS) or surfactant deficiency occurs primarily in premature infants resulting in composite outcomes of death or bronchopulmonary dysplasia. Initial management strategies for preterm infants with RDS includes early initiation of continuous positive airway pressure (CPAP) and titration of fractional inspired oxygen (FiO2), and may include the use of less invasive surfactant administration (LISA) to avoid the need for mechanical ventilation. In order to optimise success of non-invasive support, the use of early caffeine therapy may be critical to the success of LISA. The objective of our trial is to evaluate whether infants that receive early caffeine, CPAP and surfactant via the LISA method compared with infants that receive caffeine and CPAP alone, have a decreased need for invasive mechanical ventilation in the first 72 hours of life.Methods and analysisCaLI is an unblinded multicentre, randomised controlled, trial of 180 preterm infants (24+0-29+6 weeks corrected GA). Criteria for intubation/treatment failure will follow guidelines for the management of RDS, including: (1) CPAP level of 6-8 cmH20 and FiO2 >0.40 required to maintain saturations 90%-95% for 2?hours after randomisation; (2) a pH of 7.15 or less or a paCO2 >65?mm Hg on any (2) blood gases (arterial/capillary/or venous) at least 2?hours after randomisation and in the first 72 hours of life; (3) continued apnoea/bradycardia/desaturation events despite nasal intermittent minute ventilation mode of ventilation. Infants will be randomised by 1?hour of life and caffeine/LISA treatments administered by 2?hour of life. Caffeine will be administered prior to surfactant in the LISA arm and before 2?hours of life in the control arm.Ethics and disseminationChiesi Farmaceutici, S.p.A is the sponsor of CaLI. Ethical approval has been obtained. Results will be submitted for publication in peer reviewed journals.Trial registration numberwww.Clinicaltrials.gov: NCT04209946; Pre-results.
| S-EPMC7825253 | biostudies-literature
Project description:ObjectiveTo evaluate how frequently surfactant is used off-label in preterm infants.Study designWe conducted a retrospective cohort analysis of prospectively collected administrative data for 2005-2015 from 348 neonatal intensive care units in the US. We quantified off-label administration of poractant alfa, calfactant, or beractant in inborn infants born at <37 weeks of gestational age (GA). Off-label surfactant administration was defined according to the Food and Drug Administration (FDA) label.ResultsOf a total of 110 822 preterm infants who received surfactant, 68 226 (62%) received the surfactant off-label. The majority of infants who received surfactant off-label had a higher birth weight than those who received surfactant on-label (40 716 [37%]), had an older GA than those who received surfactant on-label (35 191 [32%]), or were treated with intubation and surfactant administration followed by immediate extubation (INSURE) (32 310 [29%]). Poractant alfa was administered via INSURE more frequently than beractant or calfactant (16 688 [38%], 7137 [20%], and 8485 [27%], respectively). An increasing number of infants received surfactant via INSURE from 2005 to 2015 (from 1697 [19%] to 3368 [36%]).ConclusionsThe majority of surfactant given to preterm infants is administered off-label. The uptrend in administration via INSURE coincides with increased supporting evidence. The gap between FDA labeling and current clinic practice exemplifies an opportunity for label expansion, which may require additional prospective or retrospective safety and/or effectiveness data for infants of older GA and higher birth weight.
| S-EPMC6486873 | biostudies-literature
Project description:AIM:Less invasive surfactant administration (LISA) has been shown to decrease the risk of death and bronchopulmonary dysplasia in preterm neonates. The LISAcath is the first catheter to be specifically developed for LISA, and we compared the clinical impressions of neonatologists using the LISAcath and the commonly used Angiocath in a simulated setting. METHODS:This was a multinational, multicentre study, conducted in October 2016, which involved 39 neonatologists who were recruited by employees of the sponsor from large, well-recognised neonatal intensive care units across Europe. LISA was not the standard of care in these units in Austria, Belgium, Poland, Spain and the United Kingdom at the time of the study. After training, participants simulated LISA on a neonatal manikin, once with the LISAcath and once with Angiocath, then answered a 10-item questionnaire. RESULTS:The responses to nine of 10 questions showed that 67-95% of the respondents preferred the LISAcath to the Angiocath, with most of the remainder indicating no preference. The only exception was the luer connection question, with two-thirds expressing no preference. The LISAcath was considered potentially safer by 33 of 39 participants, with no votes for the Angiocath. CONCLUSION:Overall, neonatologists preferred using the LISAcath rather than the Angiocath on a neonatal manikin.
| S-EPMC5947293 | biostudies-literature
Project description:BackgroundOne 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).MethodsProLISA 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.DiscussionThis 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 registrationClinicalTrials.gov: NCT04016246. Registered 06 June 2019, N°EUDRACT: 2018-002876-41.
| S-EPMC7206779 | biostudies-literature
Project description:Spontaneous preterm birth significantly contributes to the overall neonatal morbidity associated with preterm deliveries. Nearly 50% of cases are associated with microbial invasion of the amniotic cavity followed by an inflammatory response. Robust diagnostic tools for neonates jeopardized by infection and inflammation may thus decrease the overall neonatal morbidity substantially. Amniotic fluid retrieved during labor retains fetal and pregnancy-related protein fingerprint and its sampling does not place any unwanted stress on women. Using exploratory and targeted methods we analyzed proteomes of amniotic fluid sampled at the end of spontaneous preterm labor prior to delivery from women with and without infection and inflammation. Exploratory data indicated several amniotic fluid proteins to be associated with infectious-inflammatory complications in spontaneous preterm birth. LC-SRM analysis subsequently verified statistically significant changes in lipocalin-1 (P = 0.047 and AUC = 0.67, P = 0.046), glycodelin (P = 0.013 and AUC = 0.73, P = 0.013), and nicotinamide phosphoribosyltransferase (P = 0.018 and AUC = 0.71, P = 0.01).
| S-EPMC4450245 | biostudies-literature