Clinical trials: Neonates or Premature Babies
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Infant, Premature, Diseases, Fatty Acid Deficiency
Prospective Evaluation in Older Premature, Untreated Breast Milk and Milk Processed by the Breast-milk Bank
The purpose of this study is to evaluate the impact of the enteral nutrition type (untreated breast milk, or breast milk processed by the breast-milk bank) on the longitudinal evolution of the total content and plasma profile of…
- Trial name
- ADiLL (NCT01626508)
- Where
- 2 sites in France
- Volunteers
- 9 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Feeding; Difficult, Newborn, Premature Infant Disease
Psychometric Properties of the SMART Feeding Tool
This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit. The main questions it aims to answer are: 1.
- Conditions
- Feeding; Difficult, Newborn, Premature Infant Disease, Dysphagia of Newborn, Nurse's Role
- Trial name
- NCT05729828
- Where
- 4 sites in United States
- Volunteers
- 76 people
- Sponsor
- Wake Forest University Health Sciences
Neonatal Respiratory Distress Syndrome, Inflammatory Response
Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS
An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide.
- Conditions
- Neonatal Respiratory Distress Syndrome, Inflammatory Response, Premature Lungs, Neutrophil Extracellular Trap Formation
- Trial name
- NCT06367881
- Testing
- Alveofact, Budesonide
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks
Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants
Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies.
- Conditions
- Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Neurodevelopmental Disorder, EEG; Spikes, Centrotemporal, Epilepsy of Childhood
- Trial name
- NCT01942525
- Testing
- aEEG
- Where
- Austria
- Volunteers
- 156 people
- Sponsor
- Medical University of Vienna
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care for up to 90 days to develop Essential Fatty Acid Deficiency (EFAD).
- Trial name
- NCT02476994
- Testing
- Clinolipid, Intralipid
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Baxter Healthcare Corporation
Necrotizing Enterocolitis
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization
The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control…
- Trial name
- ECUN-2 (NCT04584320)
- Testing
- Stool sample
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Respiratory Distress Syndrome, Preterm Pregnancy
Less Invasive Surfactant Administration in Late Preterm or Early Term Born Infants
The aim of this study is to see if giving less invasive surfactant administration (LISA) during high-flow nasal cannula (HFNC) oxygen treatment reduces the need for invasive ventilation in babies with breathing problems born 2-6…
- Conditions
- Respiratory Distress Syndrome, Preterm Pregnancy, Surfactant Deficiency Syndrome Neonatal
- Trial name
- NCT06421506
- Testing
- Less invasive surfactant administration during high flow nasal cannula treatment
- Where
- United Kingdom
- Volunteers
- 245 people
- Sponsor
- King's College Hospital NHS Trust
Bronchiolitis; Respiratory Syncytial Virus
RSV Seasonality in Martinique in Children Aged 2 Years or Less
The epidemiological characteristics of RSV bronchiolitis differ between tropical and temperate zones. This study seeks to understand which climatic factors could influence the specific seasonality of these bronchiolitis in…
- Trial name
- VRS-12 (NCT04415229)
- Where
- Martinique
- Volunteers
- 1,237 people
- Sponsor
- University Hospital Center of Martinique
Procedural Pain
Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates. The objective is to test this hypothesis in a randomized, controlled study using a standardized and…
- Trial name
- BMoS (NCT00908401)
- Testing
- Breastmilk, Oral Sucrose
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Centre Hospitalier Intercommunal Creteil
Healthy Volunteers
Early Environmental and Maternal Determinants of Airway Inflammation in Wheezing Disorders in Infants
This study collects data on microbiological, genetic and environmental factors, as well as lung function parameters (e.g. spirometry, body plethysmography, lung-MRI) to assess the complex interaction of predisposing risk factors…
- Trial name
- NCT04286464
- Testing
- No intervention
- Where
- Switzerland
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Respiratory Distress Syndrome, Newborn, Apnea of Prematurity
NIV-NAVA Versus Nasal Continuous Positive Airway Pressure (nCPAP) or Non Synchronized NIPPV
Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS) and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive pressure (barotrauma), excessive gas delivery…
- Trial name
- Bio-NAVA (NCT02860325)
- Testing
- NIV-NAVA, Conventional
- Where
- Spain
- Volunteers
- 56 people
- Sponsor
- Complejo Hospitalario Universitario Insular Materno Infantil
Retinopathy of Prematurity
Infant-parent Skin-to-skin Contact During Screening for Retinopathy
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced.
- Trial name
- NCT02780544
- Testing
- skin-to-skin contact, incubator, Sucrose
- Where
- Norway
- Volunteers
- 34 people
- Sponsor
- St. Olavs Hospital
Cesarean Section, Infant Conditions
Intact-cord Stabilisation and Physiology-based Cord Clamping in Caesarean Sections
This is a feasibility study with historical control designed to evaluate whether delivery of the placenta prior to umbilical cord clamping at caesarean sections is a feasible, safe and acceptable way of facilitating intact-cord…
- Trial name
- INTACT (NCT05461950)
- Testing
- Extrauterine placental transfusion and physiology-based umbilical cord clamping, Extrauterine placental transfusion, intact cord stabilisation and physiology-based umbilical cord clamping, Delayed umbilical cord clamping
- Where
- Norway
- Volunteers
- 263 people
- Sponsor
- Helse Møre og Romsdal HF
Acute Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Invasive Ventilation Strategies for Neonates With Acute Respiratory Distress Syndrome Syndrome (ARDS)
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.
- Conditions
- Acute Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, High Frequency Oscillation Ventilation
- Trial name
- NCT03372525
- Testing
- HFOV, CMV
- Where
- China
- Volunteers
- 400 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Bronchopulmonary Dysplasia
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5…
- Trial name
- NCT00931632
- Testing
- Inhaled Nitric Oxide
- Where
- 33 sites in United States, Canada
- Volunteers
- 451 people
- Sponsor
- Mallinckrodt
RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal
Surfactant Administration by Insure or Thin Catheter
This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy.
- Conditions
- RDS of Prematurity, Surfactant Deficiency Syndrome Neonatal, Analgesia
- Trial name
- SAINT (NCT04445571)
- Testing
- Thin catheter technique or standard ET-tube for surfactant administration
- Where
- Sweden
- Volunteers
- 160 people
- Sponsor
- Karolinska Institutet
Neuroimaging
Evaluation of the Implementation of the Hemispheric Dominance During Development
Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the…
- Trial name
- HEMISPHERENOR (NCT02826733)
- Testing
- Electroencephalogram (EEG), Near Infra Red Spectroscopy (NIRS), magnetic resonance imaging (MRI)
- Where
- France
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
A research study that will evaluate if giving surfactant medication to premature babies weighing < 1250 gm at birth during the second and third weeks of life will help their lungs.
- Trial name
- NCT00208039
- Testing
- Infasurf
- Volunteers
- 89 people
- Sponsor
- Children's Hospital of Philadelphia