18 results
To determine whether administration of exogenous surfactant using a minimally-invasive technique improves outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP).
In this research study we compare two approaches that can be used to give breathing support to prematurely born babies. Both techniques are currently used in different countries over the world. However, at this moment we don*t know which methods is…
To evaluate the safety and efficacy of lucinactant for inhalation, in comparison to nasal continuous positive airway pressure (nCPAP) alone, inpreterm neonates with RDS, as assessed by the time to, and incidence of, respiratory failure and/or death…
In this multicenter trial we compare resuscitation of preterm neonates with either 5 cm H2O PEEP or 8 cmH2O PEEP. We think resuscitation with 8 cmH2O PEEP results in a better outcome compared to resuscitation with 5 cmH2O PEEP.
Primary objective: -to determine if there is a significant difference in the incidence of oxygen dependency at day 28 and/or death within the first 28 days of life between newborns with congenital diaphragmatic hernia treated with high frequency…
To investigate the direct effect of caffeine on the respiratory effort of the preterm infant at birth.
The aim of this study is to test the hypothesis that using nasal tube as interface during resuscitation/stabilisation of preterm infants at birth is more effective compared to mask.
Does the use of NIPPV in ELBW infants (<30 wks of GA and BW<1000gr) requiring non-intubated respiratory support in a Level III perinatal center increase the rate of survival without BPD when compared to nCPAP.
Primary objective- Survival without BPD at 36 weeks gestational age (GA)Secondary objectives- Neurodevelopment at a corrected age of 18-22 months- Adverse treatment effects- Mortality at 36 weeks gestational age- BPD incidence at 36 weeks…
The main objective is to improve exercise tolerance. Secondary objectives are: 1) improvement of motor function development, daily physical activity, quality of life, self perception of motor competence, and participation; 2) evaluation of cost…
To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of positive pressure ventilation to preterm infants at birth will increase the proportion of tidal volumes within a predefined *safe range* of 4 -…
Primary Objectives: The primary objectives of this study are to evaluate the efficacy and safety of IV sildenafil when added to iNO for the treatment of neonates with PPHN or hypoxic respiratory failure and at risk for PPHN. Secondary Objectives: *…
Primary ObjectivesPart A:To determine the pharmacokinetics (PK) of intramuscular (IM)administrations of REGN2222Part B:To demonstrate the efficacy of REGN2222 in preventing medicallyattended respiratory syncytial virus (RSV) infections (subjects…
The objective of this study is to analyse the hypothesis that intravenous milrinone used in conjunction with iNO results in the reduction in the time on iNO therapy and the time spent on invasive ventilation in infants * 34 weeks gestation and *…
Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…
This study has been transitioned to CTIS with ID 2024-515914-41-00 check the CTIS register for the current data. The primary objective of this study is to assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the…
The objective of this study is to determine the optimal lower oxygen saturation target in children with moderate-severe BPD, i.e. children who are oxygen-dependent at 36 weeks PMA.
This study has been transitioned to CTIS with ID 2024-515625-29-00 check the CTIS register for the current data. The main objective of our trial is to investigate if doxapram is safe and effective in reducing the composite outcome of death and…