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MULTICENTRE RANDOMISED CONTROLLED TRIAL
OF MINIMALLY-INVASIVE SURFACTANT THERAPY IN
PRETERM INFANTS 25-28 WEEKS GESTATION
ON CONTINUOUS POSITIVE AIRWAY PRESSURE

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).

The Sustained Aeration of Infant Lungs Study

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…

A MULTINATIONAL, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED
STUDY TO ASSESS THE SAFETY AND EFFICACY OF LUCINACTANT FOR
INHALATION IN PRETERM NEONATES 26 TO 32 WEEKS GESTATIONAL AGE
WITH RESPIRATORY DISTRESS SYNDROME.

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…

Pharmacokinetic and pharmacodynamic modelling of routinely used off label drugs in premature neonates

Recently, population PK/PD modeling and simulation studies have enabled the development of evidence-based individualized dosing schemes for children with a limited number of subjects, thus improving drug safety and efficacy. The application of PK/PD…

PEEP resuscitation in preterm neonates, a double blinded, randomized, controlled trial comparing 5cmH2O and 8cmH2O PEEP.

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.

Pilot study: Randomised controlled trial of interface use during stabilisation of preterm infants in the delivery room

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.

Nasal Intermittent Positive Pressure Ventilation for Premature Infants

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.

Reducing Apneas in Preterm Infants: Low-Flow versus Caffeine

The main objective of this study is to determine if Low-Flow is non inferior in reducing apneic spells compared to caffeine. Secondary objectives are investigating if these treatments have an effect on the need of supplemental ventilation and on the…

Improvement of physical endurance and motor function performance in children with anatomical congenital anomalies and/or following neonatal extracorporeal membrane oxygenation; a randomized study

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…

A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT

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: *…

Aerosolised salbutamol in two doses as a treatment for preterm infants with developing bronchopulmonary dysplasia.

Is a higher dose of aerosolised salbutamol as a treatment for preterm infants suspected for developing BPD more effective than a lower dose on short-term clinical effects?

Safety and feasability of Predictive Intelligent Control of Oxygenation (PRICO) on the Neonatal Intensive Care Unit (NICU)

To test the safety and feasibility of a closed loop controller of the FiO2 based on the measured SpO2 in a NICU setting.

The Use of Milrinone in Neonates with Persistent Pulmonary Hypertension of the Newborn: A Randomised Controlled Trial Pilot Study

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 *…

Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

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…

Multicenter study of the performance of Fabian-PRICO for saturation targeting routine use in the NICU

Investigate whether, in a routine clinical environment across a number of centers, the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.

Positive end-expiratory pressure levels during resuscitation of preterm infants at birth

The specific trial aim is to establish whether the use of a high, dynamic 8-12 cmH2O PEEP level strategy to support the lung during stabilisation at birth, compared with a static 5-6 cmH2O PEEP level strategy, increases the rate of survival without…

Immediate Stimulation to Prevent and Inhibit cardiorespiratory Events in preterm infants

Evaluate the safety and feasibility of providing automated tactile stimulation in response to apnea, bradycardia and/or desaturation using the BreatheBuddy.

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

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…

Supplemental oxygen strategies in children with bronchopulmonary dysplasia (BPD) after the neonatal intensive care unit: the SOS BPD study.

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.

Doxapram versus placebo in preterm newborns:
an international double blinded multicenter randomized controlled trial.

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…