Clinical trials: Very Preterm Infant
Prematurity, Oxidant Injury
Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight Infants
We propose a preliminary trial to evaluate the safety and efficacy of using more restricted oxygen during resuscitation for VLBW infants than is utilized currently in an effort to reduce the oxidant stress of such treatment, and…
- Trial name
- NCT00369720
- Testing
- Titration of oxygen in delivery room
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Neil Finer
Influenza
Study of Live, Attenuated Influenza Vaccination in Preterm and Full-Term Infants
Severe influenza respiratory disease is increasingly recognized in children. Influenza hospitalization rates in high-risk infants, such as premature infants, are increased some five-fold over rates in other children.
- Trial name
- NCT01194297
- Testing
- Live attenuated influenza vaccine, Inactivated influenza vaccine
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- University of Rochester
Preterm Birth
Human Milk in Preterm Infants
Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.
- Trial name
- NCT05228535
- Testing
- Human milk fortifier
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Augusta University
Respiratory Distress Syndrome
A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants
The purpose of this study is to see if a medication called Curosurf can reduce the length of time that small premature babies with Respiratory Distress Syndrome (immature lungs) or RDS, stay on the ventilator, as compared to the…
- Trial name
- NCT01709409
- Testing
- Curosurf-Group1, BLES-group 2
- Where
- Canada
- Volunteers
- 88 people
- Sponsor
- Ottawa Hospital Research Institute
Prone Positioning, Bronchopulmonary Dysplasia
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
In this pilot study, the investigator team aims to evaluate whether standardized prone positioning compared to usual positioning improves moderate to severe bronchopulmonary dysplasia (BPD) rates as assessed at 36 weeks post…
- Trial name
- NCT04890158
- Testing
- Prone positioning for a total of 6 hours daily
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
Feeding; Difficult, Newborn, Necrotizing Enterocolitis
A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants
The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2)…
- Trial name
- NCT01337921
- Testing
- Multi-strain Probiotic
- Sponsor
- University of Nebraska
Preterm Birth
The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?
To establish if placental transfusion, using deferred cord clamping for 60 seconds or more while holding the baby at or below the level of the placenta, will improve survival without disability compared with standard early cord…
- Trial name
- APTS (NCT02606058)
- Testing
- Deferred cord clamping
- Where
- 26 sites in United States, Australia and 5 more
- Volunteers
- 1,637 people
- Sponsor
- University of Sydney
Bronchopulmonary Dysplasia, Child Development
Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study
This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe…
- Conditions
- Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
- Trial name
- NCT05915806
- Testing
- High-dose DHA, Control
- Where
- Canada
- Volunteers
- 1,801 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Neonatal Cerebral Leukomalacia, Intracranial Nontraumatic Haemorrhage of Fetus and Newborn
The Role of Cerebral NIRS in Preventing Brain Injury of Very Low Birth Weight Preterm Infants
This study determines the effectiveness of cerebral Near Infrared Spectroscopy (NIRS) as a monitoring device combined with a SafeboosC treatment guideline in order to prevent brain injury in very low birth weight preterm…
- Conditions
- Neonatal Cerebral Leukomalacia, Intracranial Nontraumatic Haemorrhage of Fetus and Newborn, Neonatal Mortality
- Trial name
- NCT06729398
- Testing
- NIRS, SafeboosC
- Where
- Indonesia
- Volunteers
- 129 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Neonatal, Pain Measurement
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the…
- Conditions
- Neonatal, Pain Measurement, Reanimation
- Trial name
- NIPEpréma (NCT05223790)
- Testing
- Pain measurement during care procedures in neonatal reanimation
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Lille
Infant, Very Low Birth Weight
Sucking Pattern of Preterm Infants Using Cup or Bottle Before Breastfeeding
The aim of this study is evaluates the effect of the use of bottle and cup in breast sucking patterns in preterm infants. It will be a randomized blind study.
- Trial name
- NCT00703950
- Testing
- cup feeding, bottle feeding
- Where
- Brazil
- Volunteers
- 56 people
- Sponsor
- Instituto Fernandes Figueira
Preterm
Early Childhood (2-year) Outcomes Among Former VLBW From the ReDiMOM Trial
The goal of this study is to determine the long-term outcomes associated with an economic intervention that was provided to encourage mother's of very premature infants to provide mother's own milk.
- Trial name
- NCT07702318
- Where
- United States
- Volunteers
- 275 people
- Sponsor
- Rush University Medical Center
Infant, Premature, Diseases, Circulatory and Respiratory Physiological Phenomena
Dose-finding for Dobutamine During Transitional Circulation in Very Preterm Infants
Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks' gestation during…
- Trial name
- NeoCirc-002 (NCT06878742)
- Testing
- Intravenous dobutamine 5 mcg/kg/min, Intravenous dobutamine 7.5 mcg/kg/min, Intravenous dobutamine 10 mcg/kg/min
- Where
- 3 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Infant, Very Low Birth Weight
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.
- Trial name
- NCT00760942
- Testing
- Similac special care 30, Similac human milk fortifier
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Oklahoma
Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema
Very Early Surfactant and NCPAP for Premature Infants With RDS
The present study will test the use of very early nasal continuous airway pressure(NCPAP)with and without surfactant in premature infants with clinical evidence or respiratory distress syndrome.
- Conditions
- Respiratory Distress Syndrome, Pneumothorax/Pulmonary Intersticial Emphysema, Chronic Lung Disease
- Trial name
- CNRNCPAP (NCT00563641)
- Testing
- Very early surfactant and bubble NCPAP, bubble NCPAP
- Where
- Colombia
- Volunteers
- 278 people
- Sponsor
- Colombian Neonatal Research Network
Prematurity; Extreme
High Flow Nasal Cannula in Preterm Infants
The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.
- Trial name
- HIFLO (NCT03007056)
- Testing
- High flow nasal cannula
- Where
- France
- Volunteers
- 207 people
- Sponsor
- Hôpital de la Croix-Rousse
Preterm Infants, Post Traumatic Stress Disorder
Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
The purpose of this study is to assess the emotional well being of mothers to preterm infants with ELBW 5-15 years after the birth. Post-traumatic symptoms and parental stress levels will be taken into consideration.
- Conditions
- Preterm Infants, Post Traumatic Stress Disorder, Emotional Stress, Infant, Very Low Birth Weight
- Trial name
- NCT01430832
- Where
- Israel
- Volunteers
- 95 people
- Sponsor
- Sheba Medical Center
Liver Diseases
Half-life of Plasma Phytosterols in Preterm Infants on Parenteral Nutrition
The purpose of this study is to determine plasma phytosterols half-lives in preterm infants who received intravenous soy oil-based lipid emulsions.
- Trial name
- NCT02758834
- Volunteers
- 45 people
- Sponsor
- Università Politecnica delle Marche
Temperature Regulation; Disorder, Fetus or Newborn
Effect of Drying Before Plastic Wrapping on Thermal Losses in Very Preterm Infants at Birth
This is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth.
- Trial name
- NEODRY (NCT05740072)
- Testing
- Drying before wrapping, No drying before wrapping
- Where
- Italy
- Volunteers
- 346 people, healthy volunteers welcome
- Sponsor
- University Hospital Padova
Respiratory Distress Syndrome, Newborn
Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies…
- Trial name
- Curpap (NCT00501982)
- Testing
- Poractant alfa (Curosurf®)
- Where
- 5 sites in Czechia, France and 3 more
- Volunteers
- 208 people
- Sponsor
- Chiesi Farmaceutici S.p.A.