Clinical trials: Premature Birth of Newborn
Behavior, Child
Effect of Kangaroo Mother Care Versus Hammock Positioning
Aim This study aimed to investigate the effect of kangaroo mother care (KMC)versus hammock positioning (HP) on physiological indices and behavioral organization among preterm neonates.
- Trial name
- Kangaroo (NCT05165004)
- Testing
- Kangaroo Mother Care, Hammock Positioning, Routine Care of NICU
- Where
- Egypt
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Alexandria University
Bronchopulmonary Dysplasia
Lung Ultrasound Score for Early Prediction of Bronchopulmonary Dysplasia in Preterm Newborns
Bronchopulmonary dysplasia (BPD) is one of the most common and severe complications of extreme prematurity, affecting approximately 40% of infants born before 28 weeks of gestation.
- Trial name
- LUS_BPD (NCT07633184)
- Testing
- Lung ultrasound at 7 (±1) days of life, Lung ultrasound at 14 (±2) days of life
- Where
- 4 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
Infant, Premature, Diseases, Bronchopulmonary Dysplasia
A Trial of Infant Flow Biphasic Nasal Continuous Airway Pressure (NCPAP) Versus Infant Flow NCPAP for the Facilitation of Extubation in Infants </= 1250 Grams
The purpose of this study is to compare two methods of delivering Nasal Continuous Airway Pressure (NCPAP): Biphasic Mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung…
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Apnea of Prematurity
- Trial name
- NCT00308789
- Testing
- Biphasic Infant flow NCPAP, CPAP
- Where
- Canada
- Volunteers
- 136 people
- Sponsor
- Mount Sinai Hospital, Canada
Retinopathy of Prematurity
Pain Response During Examination for Retinopathy of Prematurity
Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old.
- Trial name
- ROP (NCT00648687)
- Testing
- suck 12.5% dextrose in water 5 minutes before the procedure
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- National Bioethics Commission of Brazil
Pain, Premature
Facilitated Tucking Position, Gentle Human Touch Practices and Pain
This prospective study is planned as a randomized controlled study to evaluate the effect of facilitated tucking position and gentle human touch practices on the pain experienced by newborns during heel blood collection.
- Trial name
- NCT05948098
- Testing
- Facilitated Tucking Position, Gentle Human Touch
- Where
- Turkey (Türkiye)
- Volunteers
- 98 people
- Sponsor
- Adiyaman University Research Hospital
Preterm Birth, Postpartum Depression
COntact RElationship in Neonatal Intensive Care Unit
The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the…
- Trial name
- CORE in NICU (NCT06462638)
- Testing
- Neurobehavioral states and physiological parameters evaluation, Maternal vocal pitch evaluation to assess depressive/anxious state
- Where
- Italy
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
Premature Infant
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
The main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during SSC between the preterm infant and his (her) parent.
- Trial name
- PO-A-PO-PREMA (NCT03827252)
- Where
- France
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Hyper Bilirubinemia, Premature Infant
Cycled Phototherapy
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (< 750 g BW or <27 weeks GA).
- Trial name
- NCT03927833
- Testing
- Phototherapy lights
- Where
- 19 sites in United States
- Volunteers
- 1,700 people
- Sponsor
- NICHD Neonatal Research Network
Patent Ductus Arteriosus
Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.
- Trial name
- NCT01536158
- Testing
- Oral paracetamol, Oral ibuprofen
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
Retinopathy of Prematurity
Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)
Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency.
- Trial name
- NCT04191954
- Testing
- Fasudil eye drops (concentration 0.5 percent), receive artificial tears drop
- Where
- Iran
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Shahid Beheshti University of Medical Sciences
Bronchopulmonary Dysplasia, BPD
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants.
- Trial name
- NCT04003857
- Testing
- PNEUMOSTEM®, normal saline
- Where
- 2 sites in South Korea
- Volunteers
- 60 people
- Sponsor
- Medipost Co Ltd.
PPROM, Preterm
Preterm Rupture of Membranes Optimising Antibiotics Trial
The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes…
- Trial name
- PROMOAT (NCT06906757)
- Testing
- Erythromycin 250mg and Amoxicillin 500mg
- Volunteers
- 3,900 people
- Sponsor
- University of Melbourne
Single-ventricle, Infant Conditions
PK/PD of Digoxin in Infants With SVHD
The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in…
- Conditions
- Single-ventricle, Infant Conditions, Infant, Newborn, Diseases, Infant, Premature, Diseases
- Trial name
- Digoxin R01 (NCT06613477)
- Testing
- PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Duke University
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
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
Respiratory Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD)
Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?
The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk…
- Trial name
- NCT07447739
- Testing
- Betamethasone
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Khang Nguyen
Previous; Cesarean Section, Cicatricial, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn, Prelabor Rupture of Membranes
Balloon Induction of Labor in PROM for TOLAC
A prospective randomized controlled trial to evaluate the safety and efficacy of labor induction with a double balloon catheter (Atad Ripener Device) in women desiring TOLAC (trial of labor after cesarean) with PROM (pre labor…
- Trial name
- BILROM-TOLAC (NCT03399266)
- Testing
- Double Balloon catheter for induction of labor
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Soroka University Medical Center
Retinopathy of Prematurity (ROP)
Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)
- Trial name
- NCT06717412
- Testing
- Conbercept
- Where
- 3 sites in China
- Volunteers
- 146 people
- Sponsor
- Wang Yusheng
Premature Birth
Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube
Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing. In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous…
- Trial name
- PREMALIM (NCT06634329)
- Testing
- Oro or Nasogastric tube feeding
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Strasbourg, France
Preterm Infant, BPD - Bronchopulmonary Dysplasia
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease.
- Conditions
- Preterm Infant, BPD - Bronchopulmonary Dysplasia, Barotrauma
- Trial name
- NCT03242057
- Testing
- NAVA, NIPPV
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Florida
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