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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…

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…

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.

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…

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…

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…

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…