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A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Primary objective: To assess the efficacy of treatment with ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding. Defined as first day of reaching three consecutive days of…

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest

Primary objective: To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile * born at 26-32 weeks GA. * According to Fenton preterm growth chart. Secondary…

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…

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…

RIC-NEC Phase II Feasibility Randomized Controlled Trial: Remote Ischemic Conditioning in Necrotizing Enterocolitis

Primary Endpoint: Feasibility of including patients in the study, randomization and delivery of the intervention. To assess the primary endpoint, we will examine the probability that: (1) a screened patient is eligible; (2) an eligible patient…

The effect of an isocaloric, protein- and mineral-enriched ('postdischarge') formula on growth, body composition and bone mineralization of late preterm infants.;Follow-up: The effect of an isocaloric, protein- and mineral-enriched (*postdischarge*) formula on growth, body composition and neurocognitive development of late preterm infants at the corrected age of 2 years.

The main objective is to compare growth and body composition of late preterm infants at 6 months corrected age, fed either an isocaloric, protein- and mineral-enriched ('postdischarge') formula (PDF) or standard term formula (TF) between…

Primary pOsterioR TRacheopexy prevents collapse of the trachea in newborns with esophageal AtresIa and Tracheomalacia

The aim of this study is to evaluate if a PPT can significantly decrease - or possibly prevent - the collapse of the trachea in newborns with EA and moderate or severe TM. Additionally, the study aims to determine whether the observed effect of PPT…

Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates.

This study has been transitioned to CTIS with ID 2024-518498-32-01 check the CTIS register for the current data. The project*s overarching aim is to diminish respiratory disease burden in moderate-late preterm born infants in their first year of…

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…