Clinical trials: Neonatal Prematurity
Infant, Newborn, Infant, Low Birth Weight
Dexamethasone Therapy in VLBW Infants at Risk of CLD
Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- Dexamethasone (NCT00011362)
- Testing
- Dexamethasone Early, Dexamethasone Late
- Where
- 13 sites in United States
- Volunteers
- 371 people
- Sponsor
- NICHD Neonatal Research Network
Moral Distress
The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
Due to highly specialized medical care neonatal care providers are faced with numerous responsibilities which makes neonatal care a particularly challenging and stressful work environment.
- Trial name
- MoD (NCT06836323)
- Where
- Switzerland
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Premature; Infant, Light-for-dates, Breastfeeding
Probiotics and Early Microbial Contact in Preterm Neonates
Probiotics are live microbes which, when administered in sufficient amounts, confer a health benefit to the host. According to recent clinical trials, administration of probiotics to very low birth weight infants significantly…
- Trial name
- ProPre (NCT01454661)
- Testing
- LGG, LGG+Bb-12
- Where
- Finland
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Persistent Ductus Arteriosus
Betamethasone and Closure of Ductus Arteriosus
The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality…
- Trial name
- CELESTE (NCT05987202)
- Testing
- DA closure in a population of premature infants
- Where
- France
- Volunteers
- 51 people
- Sponsor
- Hospices Civils de Lyon
Prematurity, Oxidative Injury
Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
Preterm infants are born with immature lungs and often require help with breathing shortly after birth. This currently involves administering 100% oxygen.
- Conditions
- Prematurity, Oxidative Injury, Respiratory Distress
- Trial name
- NCT00356902
- Testing
- titration of oxygen during resuscitation
- Where
- Canada
- Volunteers
- 215 people
- Sponsor
- University of Calgary
Feeding; Difficult, Newborn, Premature
A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial
Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring…
- Trial name
- NCT04945967
- Testing
- New Method, Conventional Method
- Where
- Indonesia
- Volunteers
- 70 people
- Sponsor
- Universitas Indonesia
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Malaria
Congenital and Neonatal Malaria in Mali
This study will look at blood samples taken from 300 preterm babies and newborns admitted for inpatient care at Hopital Gabriel Toure in Bamako, Mali, and to gather information that will help the investigators verify the role of…
- Trial name
- NCT00384267
- Where
- Mali
- Volunteers
- 44 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Resuscitation
Co2 Monitoring at Preterm Delivery-Observational Study
CO2 data, serving as a proxy marker for tidal volume, might enable titration of tidal volume/pressure thereby providing optimal ventilation during neonatal resuscitation.
- Trial name
- COSTA (NCT04699708)
- Testing
- Carbon dioxide monitoring
- Where
- 2 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- South Tees Hospitals NHS Foundation Trust
Bronchopulmonary Dysplasia (BPD)
Metformin for Premature Infants With Bronchopulmonary Dysplasia
The overall objective of this study is to investigate the role of metformin in decreasing lung injury and promoting lung growth in premature infants. There are two phases to this pilot study.
- Trial name
- NCT07120971
- Testing
- Metformin (open-label)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical College of Wisconsin
Psychomotor Impairment
Correlation Between Cerebral Oxygenation and Neurodevelopment in VLBW Preterm Infants.
The recent improvements in neonatal intensive care have led to a substantial increase in the survival rate of preterm infants; nevertheless, this population is still at high risk for long-term neurodevelopmental disabilities.
- Trial name
- NCT03104296
- Testing
- Griffiths Mental Development Scales
- Where
- Italy
- Volunteers
- 63 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Early-Onset Neonatal Sepsis, Antibiotic Stewardship
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset…
- Trial name
- NCT06197269
- Testing
- Short duration antibiotics, Standard duration antibiotics
- Where
- India
- Volunteers
- 75 people
- Sponsor
- Lady Hardinge Medical College
Preterm Birth, Ventilator Lung; Newborn
Cerebral Oxygenation in Preterm Neonates with Respiratory Support During Skin-to-skin Care on the First Day After Birth
This is a prospective observational pilot study investigating if skin-to-skin care (SSC) has an influence on cerebral oxygenation and perfusion measured with near-infrared spectroscopy (NIRS) compared to incubator care in…
- Trial name
- Kangaroo (NCT04865302)
- Testing
- SSC
- Where
- Austria
- Volunteers
- 43 people
- Sponsor
- Medical University of Graz
Neonatal Pain, Retinopathy of Prematurity (ROP)
Fentanyl Intranasal for Retinopathy of Prematurity Screening in Preterm Infants
The goal of this clinical trial is to learn whether intranasal fentanyl (a pain medicine given as a nasal spray) can reduce pain and is safe to use during routine eye examinations for retinopathy of prematurity (ROP) in preterm…
- Conditions
- Neonatal Pain, Retinopathy of Prematurity (ROP), Pain Management, Infant, Premature
- Trial name
- FIREFLY (NCT07112430)
- Testing
- Fentanyl Citrate (Intranasal)
- Where
- Canada
- Volunteers
- 58 people
- Sponsor
- Marsha Campbell-Yeo
Preterm
The Effect of Surgical Incision Drep Use in Endotracheal Tube Fixation
It is aimed to minimise both unplanned extubation and skin damage with the surgical incision drep that we will use to fix the endotracheal tube in neonatal preterm infants and to reduce the complications that may develop due to…
- Trial name
- NCT06832553
- Testing
- surgical incision drep
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Hasan Kalyoncu University
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Acute Kidney Injury, Drug Use
A Big Data Approach to Predict NEOnatal Acute Kidney Injury in Newborns expoSed to nephroTOxic Drugs (NeoAKI STOP)
This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach.
- Conditions
- Acute Kidney Injury, Drug Use, Drug Interaction, Drug Toxicity
- Trial name
- NeoAKISTOP (NCT05851222)
- Where
- Italy
- Volunteers
- 4,200 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Respiratory Distress Syndrome in Premature Infant
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
This study is an interventional, non-pharmacological, multicentric, randomized, controlled, superiority, non-profit study. Its primary objective is to evaluate if the administration of surfactant based on FOT assessment will…
- Trial name
- REMEDIES (NCT05791331)
- Testing
- Surfactant administration following lung mechanics assessment in addition to clinical assessment, Surfactant administration following clinical assessment
- Where
- Italy
- Volunteers
- 458 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Bronchopulmonary Dysplasia, Lung Diseases
Developmental Sequelae of Severe Chronic Lung Disorders
To determine the impact of bronchopulmonary dysplasia (BPD) on childhood development, family functioning, and parental stress.
- Trial name
- NCT00005294
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Anemia, Iron Deficiency
Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment
The investigators plan a study to randomize 540 children in Nepal to early (≤30 seconds) or late (≥180 seconds) clamping of the umbilical cord at birth.
- Conditions
- Anemia, Iron Deficiency, Neonatal Jaundice
- Trial name
- NCT02222805
- Testing
- Early (≤30 seconds) cord clamping, Delayed (≤180 seconds) cord clamping
- Where
- Nepal
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Uppsala University
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