17 results
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 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…
PrimaryTo characterise the single and multiple dose to steady state pharmacokinetics of IV zanamivirin hospitalised neonates and infants under 6 months of age with influenza infection.SecondaryTo evaluate the safety and tolerability of IV zanamivir…
Evaluate the safety and feasibility of providing automated tactile stimulation in response to apnea, bradycardia and/or desaturation using the BreatheBuddy.
Investigate whether, in a routine clinical environment across a number of centers, the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.
This study has been transitioned to CTIS with ID 2023-504999-25-00 check the CTIS register for the current data. To investigate wether the treatment of children and adolescents with AML can be improvedby means of:1) improved risk-group adapted…
Primary ObjectiveIn order to assess the effects of anti TNFα on the development of adaptive and innate immunity, children exposed to anti TNFα (with or without other immunosuppressive drugs) will be compared to children exposed to immunosuppressive…
The overall aim of the study is to gain more insight in as well as understand and map the pharmacokinetics of tacrolimus during pregnancy. Therefore, we will study tacrolimus concentrations in maternal whole blood (routine care) and via area under…
To study the most relevant outcome measures and a cost-effectiveness analysis of laparoscopic PIRS technique compared to open hernia repair in infants aged 6 months to 16 years of age with a primary unilateral inguinal hernia
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.
To compare the effect of FiO2-C in addition to manual adjustments, in comparison with manual adjustments of FiO2 only, on death and severe complications of prematurity thought to be related to hypoxia/hyperoxia and neurodevelopmental impairment in…
Clinical feasibility of the urine collection device, indicated by staff and parents.
Primary:• To evaluate the safety of ORGN001 (formerly ALXN1101) over the first 6 months of treatmentSecondary:• To characterize the pharmacokinetics (PK) of increasing doses of ORGN001 (formerly ALXN1101) • To evaluate the effect of ORGN001 (…
This study aims to investigate whether the intraoperative use of indocyanine green fluorescence angiography (ICG-FA) is feasible and safe in neonates. Feasibility is therein defined as practically possible use of ICG-FA, resulting in clear and…
Therapeutic nadroparin administration:Primary objective: To develop evidence-based dosing regimens of nadroparin for extremely premature, premature and term neonates by means of the objectification of the PK/PD of nadroparin.Secondary objective: 1)…
The aim of this study is to investigate the effects of Kangaroo care (KC), live-performed music therapy (LPMT), and combination therapy (CT) on salivary cortisol (SC) and salivary oxytocin (OT) responses in parents of preterm infants, as well as on…
To investigate oxidative stress levels in the plasma and urine of late preterm and term newborns treated for PPHN in the NICU.