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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…

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).

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…

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.

A randomized controlled trial of respiratory function monitoring during
stabilization of preterm infants at birth

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 -…

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: *…

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

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…

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?

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
EVALUATING THE EFFICACY AND SAFETY OF A HUMAN MONOCLONAL
ANTIBODY, REGN2222, FOR THE PREVENTION OF MEDICALLY ATTENDED
RSV INFECTION IN PRETERM INFANTS

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…

A randomized cross-over trial in the effect of automated oxygen control devices on the distribution of oxygen saturation in preterm infants

To compare the effect of two automated oxygen controllers (Oxygenie and CLiO2) on time spent within oxygen target range in preterm infants.

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…

Optimising Oxygenation of Preterm infants during Respiratory support by fine-tuning Automatic TItration of Oxygen

To compare the effect of two target ranges (91%-95% and 92%-96%) while on automated oxygen control on the time spent under the target range in preterm infants.

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 *…

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…