Clinical trials: Premature Birth of Newborn
Respiratory Distress Syndrome, Preterm Birth
nHFOV vs nCPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From RDS
The purpose of this study is to compare the effects of two different techniques of non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering from respiratory distress syndrome.
- Trial name
- NCT02772835
- Testing
- Medin-cno
- Where
- 8 sites in Italy, Lithuania
- Volunteers
- 30 people
- Sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
Necrotizing Enterocolitis
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
- Trial name
- CoolNEC (NCT01330576)
- Testing
- cooling blanket/mattress, Standard treatment of care at normothermia
- Where
- United Kingdom
- Volunteers
- 13 people
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
Bronchopulmonary Dysplasia
Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)
This is a randomized, parallel-group, double-blind, placebo-controlled multicenter phase 2b/3 study with an adaptive seamless design.
- Trial name
- ZELA (NCT06897839)
- Testing
- Zelpultide alfa
- Where
- 49 sites in Argentina, Belgium and 6 more
- Volunteers
- 366 people
- Sponsor
- Airway Therapeutics, Inc.
Fetal Membranes, Premature Rupture
Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes
Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks.
- Trial name
- NCT00259519
- Testing
- Induction of delivery
- Where
- 11 sites in Canada
- Volunteers
- 152 people
- Sponsor
- University of Alberta
Fetal Growth Retardation, Low Birth Weight
BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)
The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low…
- Conditions
- Fetal Growth Retardation, Low Birth Weight, Preterm Birth, Gestational Weight Gain
- Trial name
- Target-BEP (NCT05576207)
- Testing
- Balanced energy and protein supplement for pregnant women, Multiple Micronutrient Supplement for pregnant women
- Where
- Bangladesh
- Volunteers
- 3,390 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Pain, Stress, Physiological
The Effect of a Musical Intervention on Stress Response to Venepuncture
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress
- Trial name
- NCT03028844
- Testing
- Music therapy
- Where
- Ireland
- Volunteers
- 20 people
- Sponsor
- University College Cork
Newborn Morbidity, Newborn Asphyxia
Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal
The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities.
- Conditions
- Newborn Morbidity, Newborn Asphyxia, Delivery Preterm
- Trial name
- SaLiN (NCT06213207)
- Testing
- Simulator based training to manage asphyxia and essential newborn care using neonatalie
- Where
- Nepal
- Volunteers
- 95 people
- Sponsor
- Integrated Development Foundation Nepal
Disorder of Stomach Function and Feeding Problems in Newborn, Feeding and Eating Disorders of Childhood
Effect of Early Oral Triple Viable Bifidobacterium Intestinal Flora in Preterm
Gut of newborn preterm is sterile, immediately by the mother and the surrounding environment from microbial colonization. As the effects of diet, intestinal flora is rapidly changed.
- Trial name
- NCT02060084
- Testing
- a control group, a probiotic-supplemented group
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Wang Hua
Premature Infant Disease, Newborn Morbidity
Effects of Confortable Environment, Kangaroo Care and Music Therapy in Newborns in Neonatal Intensive Care Unit
Creating a comfortable environment, implementing kangaroo care, and incorporating music therapy are crucial interventions for newborns hospitalized in the Neonatal Intensive Care Unit (NICU).
- Trial name
- PRE-CARE (NCT06256406)
- Testing
- in the field of rehabilitation and neonatal care: the combination of Kangaroo care method and music therapy
- Where
- Italy
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Policlinico Universitario, Catania
Anemia of Prematurity, Necrotizing Enterocolitis
Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates
Despite many advances in neonatal care, necrotizing enterocolitis (NEC) remains a leading cause of morbidity and mortality among premature infants.
- Trial name
- NCT01735552
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Utah
Prematurity
Effect of Osteopathic Manipulative Treatment on Pain in Preterms
Osteopathic manipulative treatment (OMT) has been used to treat term and preterm newborns. Recent studies demonstrated the effectiveness of OMT in reducing length of stay and costs (Cerritelli, 2013) as well as the likelihood of…
- Trial name
- NCT02146677
- Testing
- Osteopathic manipulative treatment, Usual care
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- European Institute for Evidence Based Osteopathic Medicine
Patent Ductus Arteriosus, Preterm
Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even…
- Trial name
- MIPD-PDA (NCT07143201)
- Testing
- Standard Dose - Ibuprofen oral suspension, Precision Dose - Ibuprofen oral suspension
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Hamilton Health Sciences Corporation
Infant, Premature, Diseases
Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants
Human milk is the best source of enteral nutrition for the preterm infant. However during the infants first hours and days of life breastmilk from the own mother is usually not available.
- Trial name
- NCT02216292
- Testing
- Control Group, Preterm Single Donor Milk Group
- Where
- Austria
- Volunteers
- 300 people
- Sponsor
- Medical University of Vienna
Venipuncture, Pain
The Effect of Mother's Gentle Human Touch Method on Preterm Pain and Mother's Anxiety Level During Venipuncture
Newborns are frequently exposed to acute or chronic pain experience due to different invasive interventions. The American Academy of Pediatrics (AAP) recommends minimizing the pain associated with invasive procedures.
- Trial name
- NCT05727631
- Testing
- gentle human touch
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Infant, Newborn, Infant, Small for Gestational Age
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide…
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Extremely Low Birth Weight
- Trial name
- NCT01534481
- Testing
- Donor Milk, Preterm Formula
- Where
- 17 sites in United States
- Volunteers
- 483 people
- Sponsor
- NICHD Neonatal Research Network
Patent Ductus Arteriosus
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants
The purpose of this study is to determine oral paracetamol and ibuprofen efficacy and safety in relation to serum levels in closure of patent ductus arteriosus in preterm infants.
- Trial name
- NCT01544972
- Testing
- Oral paracetamol, Oral ibuprofen
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Apnea of Prematurity, Desaturation of Blood
Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants
This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%.
- Conditions
- Apnea of Prematurity, Desaturation of Blood, Central Apnea, Periodic Breathing
- Trial name
- NCT03695900
- Testing
- Targeting SpO2 at 93-95%, Targeting SpO2 at 90-92%
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- University of Miami
Pregnant Women Receive Celesten
Betamethasone and Severity of Hyaline Membrane Disease
Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.
- Trial name
- b-Mhyalines (NCT01854840)
- Where
- France
- Volunteers
- 127 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Infant, Premature, Diseases
A Single Blinded Study on the Effect of Saccharomyces Boulardii CNCM I-745 on Growth and Development in Preterm Infants
Immature gastrointestinal functions increase the risk of poor growth as well as nosocomial infections and necrotizing enterocolitis (NEC) in the preterm infant.
- Trial name
- SBP (NCT02310425)
- Testing
- S. boulardii
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Lingfen Xu, MD
Premature Birth, Brain Injuries
S100B as a Marker of Brain Injury of Preterm Infants
The improvement of treatment of preterm neonates improved their survival, however there is still significant portion of preterm infants (specifically very preterm infants) that suffers from brain insults and as a result…
- Conditions
- Premature Birth, Brain Injuries, Leukomalacia Periventricular, Developmental Disabilities
- Trial name
- PTS100B (NCT02082535)
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Sheba Medical Center
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