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An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent (NEMO).

The aim of the trial is to obtain data on the optimal dose, feasibility and pharmacokinetics of bumetanide when given as an add-on treatment for seizures in full term babies with hypoxic ischemic encephalopathy (HIE). Bumetanide will be given in a…

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.

Paracetamol intravenously in neonates with a gestational age of less than 32 weeks

Primary objective: to study the pharmacokinetics and pharmacodynamics of paracetamol intravenously in preterm infants with a gestational age of less than 32 weeks:Secondary objective(s): to study the safety and dose-effect relationship of…

Pharmacokinetics and Pharmacodynamics of Medication
in Asphyxiated Newborns During Controlled Hypothermia
PharmaCool National Multicenter Study.

This project aims to develop an evidence based effective and "safe" dosing regimen for commonly used life saving medicationsused in the treatment of asphyxiated, critically ill newborns, undergoing therapeutic hypothermia.To this aim the…

Study on Hypothermia-Induced Variations in pharmacokinetic Effect Relationships

Study (population) pharmacokinetics of midazolam, morphine, phenobarbital and lidocaïne during therapeutic hypothermia for adequate dose adjustments.

Heart rate registration in neonates using a PPG-integrated cap

Primary Objective: To assess the agreement between the heart rate assessed with a dedicated cap with integrated PPG-leads and standard ECG monitoring using regular neonatal thoracic electrodes as reference technique.Secondary objectives:Does…

Safety and efficacy of nadroparin in neonates: an observational study.

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)…

Effects of live-performed music therapy, kangaroo care and combination therapy on stress, comfort and bonding in parents of extremely preterm infants

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…

oxIdative stress in late preterM and term newborns with Persistent pulmonAry hypertension in the neonatal intensive Care uniT (IMPACT-study)

To investigate oxidative stress levels in the plasma and urine of late preterm and term newborns treated for PPHN in the NICU.

Stabilisation of preterm infants with intact umbilical cord: feasibility study

To test the safety of using the Con-Cord table for stabilization of preterm infants according to the ABC approach.