Clinical trials: Premature Infant, active
Premature Infants, Very Premature Infants
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
- Conditions
- Premature Infants, Very Premature Infants, Inflammation
- Trial name
- AP2 (NCT07254000)
- Testing
- Anakinra (Kineret®)
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 24 people
- Sponsor
- Monash Medical Centre
Preterm Birth Complication, Preterm Birth
Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
The goal of this clinical trial is to learn if a personalized prenatal support program [(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)] works to…
- Conditions
- Preterm Birth Complication, Preterm Birth, Preterm Birth Recurrence, Preeclampsia
- Trial name
- PTBCARE+ (NCT06915428)
- Testing
- Care coordination, Electronic massage, support gift #1
- Where
- United States
- Volunteers
- 1,228 people
- Sponsor
- University of North Carolina, Chapel Hill
Premature Infants
The Impact of Masseter Muscle Thickness on the Feeding Process in Preterm Infants in Ultrasound Assessment
The aim of this study is to assess masseter muscle thickness using ultrasounds during oral feeding process in premature infants with gestational age from 28+0/7 to 32+0/7 weeks, taking into account the qualitative and…
- Trial name
- NCT07656467
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Polish Mother Memorial Hospital Research Institute
Bronchopulmonary Dysplasia (BPD)
Continued Pressure for Alveolar Protection (CPAP Trial)
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at…
- Trial name
- CPAP (NCT07417111)
- Testing
- CPAP, Nasal Cannula
- Where
- 15 sites in United States
- Volunteers
- 860 people
- Sponsor
- NICHD Neonatal Research Network
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
Swiss Neonatal Network & Follow-up Group
The chief aim of the Swiss Neonatal Network \& Follow-Up Group (SwissNeoNet) is to maintain and / or improve the quality and safety of medical care for high-risk newborn infants and their families in Switzerland through a…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Asphyxia Neonatorum
- Trial name
- SwissNeoNet (NCT04239508)
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- Swiss Neonatal Network
Prematurity, Low Birth Weight Neonates
Metagenomic & Metabolomic Study: Bifidobacterium Probiotic Effects on Gut Microbiota & SCFA in Preterm NICU Infants
One million premature babies die due to prematurity complications, contributing the most to the causes of death in children under 5 years old.
- Trial name
- NCT07213414
- Testing
- Probiotics
- Where
- 3 sites in Indonesia
- Volunteers
- 72 people
- Sponsor
- Hasanuddin University
Respiratory Viral Infections, Adverse Pregnancy Outcomes
APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy
Adverse pregnancy outcomes (APOs) are a collection of conditions that have short-term and long-term effects of complications related to pregnancy and childbirth on pregnant women and their fetuses, including hypertensive…
- Trial name
- APO (NCT07257952)
- Volunteers
- 1,440 people
- Sponsor
- Shanghai General Hospital, China
Shock, Preterm Birth Complication
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g.
- Conditions
- Shock, Preterm Birth Complication, Preterm Intraventricular Hemorrhage, Asphyxia Perinatal
- Trial name
- NCT07248761
- Testing
- Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days, Vasoactive drug therapies
- Where
- Mexico
- Volunteers
- 76 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Prematurity
Ultrasound Monitoring of Muscle Thickness in Premature Patients
The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with…
- Trial name
- NeoMassage (NCT06273202)
- Testing
- Infant Massage
- Where
- Italy
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Prematurity
Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is…
- Trial name
- NCT05675397
- Testing
- donor human milk
- Where
- 2 sites in Greece
- Volunteers
- 200 people
- Sponsor
- National and Kapodistrian University of Athens
Surfactant Deficiency Syndrome Neonatal
deMISTify: The Impact of Ventilator Pressure Levels During Minimally Invasive Surfactant Therapy on Lung Aeration in Preterm Infants
Infants born preterm (before 36 weeks' gestation age) have immature lungs and struggle to breathe on their own. They are supported via respiratory machines like ventilators, as well as pharmaceutical aids like surfactant…
- Trial name
- deMISTify (NCT07522346)
- Testing
- Lung Recruitment Manoeuvre prior to Minimally Invasive Surfactant Therapy, Control (Minimally Invasive Surfactant Therapy)
- Where
- Australia
- Volunteers
- 36 people
- Sponsor
- Murdoch Childrens Research Institute
Bronchial Obstruction, Premature Birth
PREterm Infants With Bronchial Obstruction - Prospective Study of Efficacy and Safety of Inhaled Tiotropium
The purpose of this clinical trial is to evaluate the efficacy and safety of inhaled tiotropium bromide (Spiriva Respimat) in preterm-born children and adolescents suffering from chronic bronchial obstruction.
- Trial name
- PRETIO (NCT07827859)
- Testing
- tiotropium bromide (Spiriva Respimat)
- Where
- Czechia
- Volunteers
- 50 people
- Sponsor
- General University Hospital, Prague
Intraventricular Hemorrhage of Prematurity
Outcome of Intraventricular Hemorrhage in Preterm Infants
To determine the incidence and grading of IVH among preterm neonates in the NICU. To identify maternal and neonatal risk factors associated with IVH.
- Trial name
- NCT07198360
- Testing
- No intervention
- Volunteers
- 300 people
- Sponsor
- Assiut University
Premature Birth
Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care…
- Trial name
- NCT02024854
- Testing
- skin-to-skin, standard care
- Where
- 4 sites in Canada, Norway
- Volunteers
- 108 people
- Sponsor
- Norwegian University of Science and Technology
Very Preterm Infants (<32 Weeks of Gestation)
Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants
The AdVEMPrem study is exploring whether tiny particles called extracellular vesicles (EVs), which are naturally found in human milk, can help protect very premature babies from serious gut problems such as necrotizing…
- Trial name
- AdVEMPrem (NCT07402083)
- Testing
- Donor human milk extracellular vesicles (DHM-EVs)
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
Retinopathy of Prematurity
Bevacizumab Treatment For Type 1 ROP
Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases.
- Trial name
- ROP4 (NCT04634578)
- Testing
- Bevacizumab
- Where
- 26 sites in United States, Canada
- Volunteers
- 77 people
- Sponsor
- Jaeb Center for Health Research
Extremely Low Birth Weight Infants
Post-Extubation Assessment of Clinical Stability in ELBW Infants
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation…
- Trial name
- PEACE (NCT06037083)
- Testing
- Oxygen saturation probe, Near infrared spectroscopy sensors, Electrical impedance tomography
- Where
- 2 sites in Canada
- Volunteers
- 20 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Respiratory Distress Syndrome, Newborn
LISA vs Endotracheal Surfactant in Preterm Neonates: A Lung Ultrasound Distribution Study
This prospective, non-randomized, unblinded pilot study evaluates and compares the intrapulmonary distribution of exogenous surfactant in preterm neonates when administered via Less Invasive Surfactant Administration (LISA)…
- Trial name
- LISA-Ven-LUS (NCT07514481)
- Testing
- surfactant administration by ETT, surfactant administration by thin catheter
- Where
- Qatar
- Volunteers
- 22 people
- Sponsor
- Hamad General Hospital
Intraventricular Hemorrhage, Premature Birth
Intranasal Fresh Mother's Own Milk to Prevent Intraventricular Hemorrhage in Extremely Preterm Infants
Babies born very prematurely are at risk of intraventricular hemorrhage (IVH), which is bleeding in or around the fluid-filled spaces of the brain. Most IVH occurs during the first week after birth.
- Trial name
- iF-MOM-IVH (NCT07812922)
- Testing
- Intranasal Fresh Mother's Own Milk (iF-MOM)
- Volunteers
- 67 people
- Sponsor
- University of Manitoba
Breastfeeding
The Effect of Podcast Breastfeeding Training on Mothers of Preterm Infants
The aim of this study is to examine the effect of breastfeeding education provided via podcast to mothers of preterm infants admitted to the neonatal intensive care unit on the mothers' breastfeeding success, awareness…
- Trial name
- NCT07660965
- Testing
- Breastfeeding education via podcast
- Where
- Turkey (Türkiye)
- Volunteers
- 56 people
- Sponsor
- Dilek Kucuk Alemdar