Clinical trials: Premature Neonates
Bronchopulmonary Dysplasia (BPD)
Impact of the Early Life Virome Development on Bronchopulmonary Dysplasia in Preterm Neonates
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity.
- Trial name
- ELVIRE (NCT07487259)
- Testing
- Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples
- Volunteers
- 40 people
- Sponsor
- Hospices Civils de Lyon
Prematurity; Extreme
A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns
Preterm infants are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb.
- Trial name
- PREM-GH (NCT07829562)
- Testing
- Golden hour
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Bronchopulmonary Dysplasia, Necrotizing Enterocolitis
Treatment of Classic Mid-trimester PPROM by Means of Continuous Amnioinfusion
Objective: Mid-trimester preterm premature rupture of membranes (PPROM), defined as rupture of fetal mem-branes prior to 28 weeks' gestation (WG), complicates approximately 0.4-0.7% of all pregnancies and associated with very…
- Conditions
- Bronchopulmonary Dysplasia, Necrotizing Enterocolitis, Intracranial Hemorrhages
- Trial name
- AmnionFlush (NCT04696003)
- Testing
- Continuous amnioinfusion with Amnion Flush Solution through the intraamniotic catheter
- Where
- Germany
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Preterm infants born prematurely are more likely to have low zinc levels because they have less time to build up zinc before birth.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia, Growth
- Trial name
- NCT07896070
- Testing
- 1 mg/day Zinc Supplementation, 3 mg/day Zinc Supplementation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Augusta University
Pulmonary Infections
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator associated pulmonary infections. Dornase alfa has been effective in the treatment of pulmonary infections in patients with cystic…
- Trial name
- PVAIN (NCT01356147)
- Testing
- Dornase alfa
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Premature Birth of Newborn
Oral Formulation of Insulin for Preterm Infants
The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.
- Trial name
- NCT01093638
- Testing
- Oral Formulation of Insulin
- Where
- Israel
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Elgan Pharma Ltd.
Neonatal Hypotension
Early Use of Hydrocortisone in Hypotensive Very Low Birth Weight Infants
The purpose of this study is to investigate the early use of hydrocortisone in hypotensive very low birth weight infants. Based on the observations that: hypotension is a common problem in very low birthweight infants and is…
- Trial name
- NCT00358748
- Testing
- Hydrocortisone
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University of British Columbia
Preterm Delivery
Cord Milking and Activity Of The Immune System In Preterm Infants
In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in the age of 3-5 month after birth the infant start to develop them by himself.
- Trial name
- NCT02043249
- Testing
- CORD MILKING
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
Diaphragm Ultrasound, Electrical Cardiometry
Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates
This research assessed diaphragmatic ultrasound and thoracic fluid content (TFC) as potential early predictive tools for detecting NIV failure in preterm neonates.
- Conditions
- Diaphragm Ultrasound, Electrical Cardiometry, Non Invasive Ventilation (NIV), RDS of Prematurity
- Trial name
- NCT07148102
- Testing
- Diaphragmatic US, EC
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Lamiaa Khaled Zidan
Neonatal Death, Preterm Birth
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020.
- Conditions
- Neonatal Death, Preterm Birth, Low Birthweight, Neonatal Hypoglycemia
- Trial name
- NCT02605369
- Testing
- Intervention arm: An integrated package
- Where
- Uganda
- Volunteers
- 1,877 people, healthy volunteers welcome
- Sponsor
- Makerere University
Neonatal Infection
Experience of Mutaflor Suspension Use in Preterm Infants for Immunity Improvement
EcN has been registered as a medical drug under the brand name Mutaflor® SUSPENSION in Ukraine in 2010. Indications for its clinical use are acute diarrhea in infants and toddlers including those on tube feeding tube, diarrhea in…
- Trial name
- EMSUP (NCT01540162)
- Where
- Ukraine
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Odessa National Medical University
Malondialdehyde, Melatonin
Oral Melatonin as Neuroprotectant in Preterm Infants
Preterm newborns survival rates are improved, but long-term disabilities are still common. Major destructive focal lesions became less common, the most predominant lesion at present is diffuse white matter (WM damage).
- Trial name
- NCT04235673
- Testing
- melatonin
- Where
- 4 sites in Italy
- Volunteers
- 60 people
- Sponsor
- Francesca Garofoli
Bronchopulmonary Dysplasia
Trial II of Lung Protection With Azithromycin in the Preterm Infant
The hypothesis of this study is that administration of azithromycin to ventilated premature infants will decrease the incidence and severity of BPD.
- Trial name
- NCT00319956
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 220 people
- Sponsor
- Hubert Ballard
GERD, Apnea Neonatal
Effects of Vented Base Feeding Bottle in Preterm Infants With GERD Symptoms.
Aim of the study is to evaluate the effects of vented base bottles on respiration-swallow patterns and on gastroesophageal refluxes in preterm infants with clinical suspect of gastroesophageal reflux disease (GERD).
- Trial name
- FeedGERD (NCT03031288)
- Testing
- A, B
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- University of Turin, Italy
Chronic Lung Disease
Prevention of Chronic Lung Disease (CLD - Prevention Study)
Primary endpoint: prospectively identify potential biomarkers able to predict the severe course of pulmonary funcion in the first 12 months of life and realize a new profile to early identify hugh risk newborns Secondary…
- Trial name
- NCT06559670
- Testing
- Blood sampling
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Hypothermia
Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming…
- Trial name
- NCT00603837
- Testing
- NeoWrap, InfaTherm
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Oklahoma
Preterm Birth Complication, Neonatal Morbidity and Mortality
Delayed Versus Immediate Cord Clamping in Preterm Birth
The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.
- Conditions
- Preterm Birth Complication, Neonatal Morbidity and Mortality, Cord Clamping, Delayed Cord Clamping
- Trial name
- PREM-CORD (NCT07699666)
- Testing
- Delayed Umbilical Cord Clamping, Immediate Umbilical Cord Clamping
- Where
- Tunisia
- Volunteers
- 200 people
- Sponsor
- Faculty of Medicine of Tunis
Bronchopulmonary Dysplasia
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube).
- Trial name
- NCT01440647
- Testing
- Extubation to NIPPV, Extubation to CPAP
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Preterm Infant
The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants
This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).
- Trial name
- NCT05503238
- Testing
- Skin-to-skin contact, Routine care
- Where
- China
- Sponsor
- Children's Hospital of Fudan University
Patent Ductus Arteriosus
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
- Trial name
- OIDS (NCT00961753)
- Testing
- optimized ibuprofen, Standard Ibuprofen
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- OSF Healthcare System
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