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Anaesthetic management guided by cellular oxygen metabolism measurements

The primary objective of this pilot trial is to evaluate if adding mitoPO2 monitoring to standard anaesthetic management enables tissue oxygenation optimisation.

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…

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…

Effectiveness of L-serine dietary supplementation in children with a GRIN2B loss-of-function mutation: n-of-1 series

Assess the potential efficay of L-serine dietary supplementation in patients children with a GRIN2B LoS mutation.

An open label, single arm study to evaluate single and multiple dose pharmacokinetics, safety and tolerability, and to explore clinical outcomes of treatment with intravenous |(IV) zanamivir in neonates and infants under 6 months of age with confirmed complicated influenza infection

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…

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.

Preserving ovARian function through cryoprEservation and informing girLs with cancer about infertility due to gonadotoxic treatment

Patients will be included in 3 prospective cohorts, cohort A, B, C and 1 retrospective cohort, cohort 0. Cohort A: The primary objective of cohort A is to show that by implementing a standard infrastructure all newly diagnosed girls with cancer (or…

Evaluation of genetic, enzymatic, biochemical and clinical characteristics of OCTN2/CPT2/CACT/BKT deficiency to determine if new born screening is useful and feasible

To survey the clinical and biochemical characteristics of individuals diagnosed with OCTN2, CPT2, CACT or BKT deficiency or suspected with OCTN2 deficiency after NBS in the Netherlands to aid the decision on whether or not to include these disorders…

Open vs Laparoscopic hernia repair in children: A randomized controlled trial

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

A randomised, double-blind, controlled trial to evaluate the effects of a nutritional product on brain integrity in preterm infants

>Primary objective:During the intervention period (from randomisation until and including Term Equivalent Age [TEA]): To investigate the effect of the test product vs. the control product given to preterm infants born at 24+0 to <30+0…

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.

Music as Medicine
The effect of music on the development of the preterm infant

(1) Does music influence brain development of the preterm infant;(2) Does music influence length of hospital stay for the preterm infant.

Effects of closed-loop automatic control of inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants-a randomized controlled parallel group multicenter trial for safety and efficacy.

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…

Collaborating to improve neonatale care: Parental participation on the neonatal ward - the neoPartner study

To investigate the effect of FCR during hospital stay, accompanied by FICare, on parental stress at discharge in parents of preterm (born before 37 weeks of gestational age) or ill (for instance with sepsis or small for gestational age) infants…

A Pilot Study into the Use of Intraoperative Indocyanine Green Fluorescence Angiography in Young Infants & Neonates

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…

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…

Dolphin CONTINUE: A nutritional intervention aimed at improving neurodevelopmental outcome in infants at risk for or with early life brain injury

The main objective is to study the effect of the nutritional intervention versus the control product on white matter development (as assessed using tract based spatial statistics of fractional anisotropy) using a DTI scan at the corrected age of…

A Phase 2, Multicenter, Multinational, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of ORGN001 (formerly ALXN1101) in Pediatric Patients with Molybdenum Cofactor Deficiency (MoCD) Type A Currently Treated with Recombinant Escherichia coli-derived Cyclic Pyranopterin Monophosphate (rcPMP)

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 (…

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…