Clinical trials: Premature Infant Disease
Bronchopulmonary Dysplasia
TINN2: Treat Infection in NeoNates 2
The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.
- Trial name
- TINN2 (NCT02282176)
- Testing
- Azithromycin
- Where
- 16 sites in Belgium, France and 7 more
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Music Therapy
The Effects of Pacifier Activated Lullaby in VLBW Preterm Infants
Music and music therapy, live or recorded, has been introduced in the Neonatal Intensive Care Unit (NICU) of the Del Ponte hospital in Varese in addition to standard medical and nursing care, to improve premature neonates'…
- Trial name
- PAL (NCT04337476)
- Testing
- The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Ospedale di Circolo - Fondazione Macchi
Bronchopulmonary Dysplasia
Safety of Sildenafil in Premature Infants
Describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil.
- Trial name
- SIL02 (NCT03142568)
- Testing
- Sildenafil
- Where
- 15 sites in United States, Canada
- Volunteers
- 109 people
- Sponsor
- University of North Carolina, Chapel Hill
Vitamin D, Prematurity
Vitamin D Status and Dose Response in Infants
This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.
- Trial name
- NCT01042561
- Testing
- Vitamin D3
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Premature Infant, Risk Factors
Perinatal Risk Factors in Motor Development
The aim of this study is to analyze the effect of preterm gestational age, birth weight and perinatal risks factors on gross motor development of preterm infants.
- Conditions
- Premature Infant, Risk Factors, Motor Development of Premature Infants
- Trial name
- NCT07310459
- Where
- Spain
- Volunteers
- 160 people
- Sponsor
- Universidad de Murcia
Premature Retinopathy, Pain
The Effect of Ocean Sound In Premature Retinopathy Examination
Purpose: It was planned as a randomized controlled experiment in order to evaluate the effectiveness of the ocean sound on pain, comfort and physiological parameters in the NICU, Retinopathy of Prematurity (ROP) examination.
- Trial name
- NCT05203159
- Testing
- Ocean sound, Routine
- Where
- Turkey (Türkiye)
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Necmettin Erbakan University
Osteopathy, PreTerm Neonate
The Effect of Cranial Osteopathy Intervention in Preterm Babies
There are planing to have 2 groups of premature born cases. Each group will include 15 cases. Participants are need to be 28-37 weeks born and no older than post term 6 weeks. All cases are going to be evaluated.
- Conditions
- Osteopathy, PreTerm Neonate, Sensory Profiles, Colic
- Trial name
- NCT06967870
- Testing
- Osteopathic intervention, Home based exercise education
- Where
- Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University
Preterm Birth, Premature Birth
Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS)
Antenatal corticosteroids (ACS) reduce the risks of neonatal death and morbidities in preterm infants, such as respiratory distress syndrome.
- Conditions
- Preterm Birth, Premature Birth, Complication of Prematurity, Obstetric Labor, Premature
- Trial name
- SNACS (NCT05114096)
- Testing
- Celestone + Celestone
- Where
- 25 sites in Canada
- Volunteers
- 3,254 people
- Sponsor
- McMaster University
Preterm Birth
The GROWNDUP Study of Late Preterm Births
This pilot study will examine the feasibility of conducting a large randomized clinical trial (RCT) to examine the role of a novel, specialized follow-up clinic in preventing complications among late preterm infants (LPTB), born…
- Trial name
- GROWNDUP (NCT01747603)
- Testing
- Specialized LPTB clinic
- Where
- 2 sites in Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- McMaster University
Necrotizing Enterocolitis, Microbial Substitution
PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants
PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants This pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term…
- Trial name
- NCT05272579
- Testing
- Fecal Filtrate Transfer
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Cerebral Palsy Infantile, Pre-Term
Motor-voice Assessment in Infants (MAMI)
The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants..
- Conditions
- Cerebral Palsy Infantile, Pre-Term, Motor Delay, Neurodevelopmental Disorders
- Trial name
- MAMI (NCT06807203)
- Testing
- Behavioral observation
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Ohio State University
Preterm
Automated Versus Manual Oxygen Control in Preterm Babies on Respiratory Support
Babies admitted in the NICU (neonatal intensive care unit) frequently need supplemental oxygen to keep their oxygen saturation (SpO2) in target range (TR).
- Trial name
- NCT06622161
- Testing
- automated oxygen vs manual oxygen
- Where
- Pakistan
- Volunteers
- 26 people
- Sponsor
- Aga Khan University Hospital, Pakistan
Bacterial Vaginosis, Premature Birth
Probiotics for the Prevention of Premature Birth and Neonatal Related Morbidity
The trial intends to evaluate the efficacy of specially designed probiotics to prevent premature birth and related neonatal morbidity associated to intra-uterine infection.
- Conditions
- Bacterial Vaginosis, Premature Birth, Sepsis, Periventricular Leukomalacia
- Trial name
- NCT00303082
- Testing
- Lactobacillus rhamnosus GR1 and Lactobacillus reuteri RC-14
- Where
- 2 sites in Brazil
- Volunteers
- 645 people
- Sponsor
- Oswaldo Cruz Foundation
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
Neonatal Respiratory Distress Syndrome
The Use of Maternal Serum Unconjugated Estriol for Monitoring the Prevention of Neonatal Respiratory Distress Syndrome
The objective of this project is to evaluate clinical significance of measuring maternal blood estriol levels, after the administration of antenatal corticosteroids to enhance lung maturity.
- Trial name
- NCT02112513
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- Indiana University
Preterm Infants
Single-Session Physiotherapy Versus Massage in Premature Infants
This study investigates the effects of a single-session physiotherapy intervention compared to massage in premature infants hospitalized in the neonatal intensive care unit.
- Trial name
- SPIM-Preterm (NCT07207161)
- Testing
- Infant Massage, Physiotherapy (Moyer-Mileur Protocol)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Necmettin Erbakan University
Premature Birth, Brain Injury
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there maybe a period of prolonged…
- Trial name
- MIND (NCT00649961)
- Testing
- Melatonin injection
- Where
- 2 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- Imperial College London
Retinopathy of Prematurity (ROP)
Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
The main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study ROPP-2008-01 (NCT01096784).
- Trial name
- PEDAL (NCT02386839)
- Testing
- rhIGF-1/rhIGFBP-3
- Where
- 16 sites in United States, Italy and 4 more
- Volunteers
- 76 people
- Sponsor
- Shire
Apnea of Prematurity
CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
The objective of the present proposed study is to discover whether, in the nursery setting, administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing more regular with less apneic…
- Trial name
- NCT01066728
- Testing
- CO2 inhalation, Theophylline
- Where
- 2 sites in Canada
- Volunteers
- 87 people
- Sponsor
- University of Manitoba
Premature Birth
Improving Brain Development in Medically Healthy Premature Infants
Premature infants born between 28 and 33 weeks' gestation often have significant brain damage. Brain damage can be caused by the much greater stimulation the infant receives in the neonatal intensive care unit (NICU) as compared…
- Trial name
- NCT00065364
- Testing
- Newborn Individualized Developmental Care Assessment Program
- Where
- United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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