Clinical trials: Neonates or Premature Babies
Bronchopulmonary Dysplasia, Vitamin D Overdose
25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death
Several studies have demonstrated that vitamin D deficiency at birth is a risk factor of bronchopulmonary dysplasia. However, in an animal model of bronchopulmonary dysplasia vitamin D overdose has also been associated with an…
- Trial name
- 25OHVDORBPDD (NCT05944055)
- Testing
- Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?
- Where
- France
- Volunteers
- 173 people
- Sponsor
- Hospices Civils de Lyon
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
BPD
Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates
This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD or death.
- Trial name
- NCT04440670
- Testing
- autologous cord blood mononuclear cells, normal saline
- Where
- 2 sites in China
- Volunteers
- 140 people
- Sponsor
- Guangdong Women and Children Hospital
Retinopathy of Prematurity
umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)
Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients.
- Trial name
- BORN (NCT05100212)
- Testing
- cord blood-RBC concentrates, adult donor RBC concentrates
- Where
- 10 sites in Italy
- Volunteers
- 146 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Bronchopulmonary Dysplasia
Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia
This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.
- Trial name
- NCT03411018
- Testing
- Mechanical ventilation exposure
- Where
- Spain
- Volunteers
- 600 people
- Sponsor
- Manuel Sanchez Luna
Bronchopulmonary Dysplasia, Extreme Prematurity
Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia
The aim of this study is to determine if fungal colonization is associated to severe bronchopulmonary dysplasia in premature infants less than 29 weeks of gestation, and to determine if an association exists between fungal…
- Conditions
- Bronchopulmonary Dysplasia, Extreme Prematurity, Fungal Infection
- Trial name
- FunDyP (NCT05152875)
- Testing
- biological
- Where
- France
- Volunteers
- 153 people
- Sponsor
- Centre Hospitalier Sud Francilien
Surfactant, Respiratory Distress Syndrome (Neonatal)
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better.
- Trial name
- SALTI (NCT07030270)
- Testing
- Surfactant Administration through Laryngeal or Supraglottic Airway, Surfactant Administration through Thin Catheter
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Texas Southwestern Medical Center
Infant, Premature, Diseases, Continuous Positive Airway Pressure
Routine Or Selective Application of a Face Mask for Preterm Infants at Birth: the ROSA Trial
International guidelines recommend giving positive pressure ventilation (PPV) by face mask to newborns who do not breathe or have a slow heart rate at birth.
- Conditions
- Infant, Premature, Diseases, Continuous Positive Airway Pressure, Positive-Pressure Respiration, Resuscitation
- Trial name
- ROSA (NCT04500353)
- Testing
- Face mask application for CPAP and/or PPV delivery
- Where
- Ireland
- Volunteers
- 201 people
- Sponsor
- University College Dublin
Infant, Newborn, Infant, Low Birth Weight
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEC Surgery (NCT01223261)
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Distress, Transient Tachypnea of the Newborn
Effect of Supine or Prone Position After Caesarean Birth
Respiratory Distress is a frequent clinical diagnosis of babies delivered by elective Caesarean birth. There has been no study comparing the efficacy of immediately positioning a newly born infant prone vs.
- Conditions
- Respiratory Distress, Transient Tachypnea of the Newborn, Delayed Transition of the Newborn, Persistent Pulmonary Hypertension
- Trial name
- NCT01310153
- Testing
- prone positioning, Supine
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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
Retinopathy of Prematurity
Infant-parent Skin-to-skin Contact During Screening for Retinopathy
Retinopathy of prematurity (ROP) is a feared complication of premature birth. If discovered in time, the disease can be treated, and impaired vision or blindness can be reduced.
- Trial name
- NCT02780544
- Testing
- skin-to-skin contact, incubator, Sucrose
- Where
- Norway
- Volunteers
- 34 people
- Sponsor
- St. Olavs Hospital
Feeding; Difficult, Newborn, Premature Infant Disease
Psychometric Properties of the SMART Feeding Tool
This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit. The main questions it aims to answer are: 1.
- Conditions
- Feeding; Difficult, Newborn, Premature Infant Disease, Dysphagia of Newborn, Nurse's Role
- Trial name
- NCT05729828
- Where
- 4 sites in United States
- Volunteers
- 76 people
- Sponsor
- Wake Forest University Health Sciences
Pregnancy Complications, Maternal Death
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are: 1.
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection
- Trial name
- MONAS (NCT06268509)
- Testing
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Where
- Indonesia
- Volunteers
- 245 people
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Respiratory Distress Syndrome in Premature Infant
Ventilator Weaning Outcome Between NIV-NAVA and Nasal CPAP (or IMV ) Modes in Premature Neonates
Premature neonates are prone to respiratory distress and need ventilator support because of the rapid breathing and large variations in respiratory patterns.
- Trial name
- NCT04118400
- Testing
- NIV-NAVA, Nasal CPAP or NIMV mode
- Where
- Taiwan
- Volunteers
- 60 people
- Sponsor
- Taipei Medical University Hospital
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Neonates or Premature Babies, Patient With Urinary Catheter
Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
In response to restrictions related to the use of DEHP as a plasticizer for PVC medical devices (MDs), manufacturers have resorted to alternative plasticizers.
- Conditions
- Neonates or Premature Babies, Patient With Urinary Catheter, Patient Hospitalized in NICU
- Trial name
- ARMED NEO (NCT03477409)
- Testing
- plasticizers
- Where
- France
- Volunteers
- 90 people
- Sponsor
- University Hospital, Clermont-Ferrand
Diastolic Dysfunction, Neonatal Encephalopathy
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined…
- Conditions
- Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn
- Trial name
- DiFuSE (NCT06200519)
- Where
- Ireland
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- University College Cork
Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)
Effect of Support for Low-Income Mothers of Preterm Infants
Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist.
- Trial name
- NCT06362798
- Testing
- Financial Transfers
- Where
- 5 sites in United States
- Volunteers
- 420 people
- Sponsor
- University of Massachusetts, Worcester
Prematurity; Extreme, Low Birthweight, Extremely (999 Grams or Less)
Extremely Low Gestatonal Age Infants' Paracetamol Study
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
- Trial name
- Paras (NCT03641209)
- Testing
- Paracetamol 10mg/mL infusion solution
- Where
- Finland
- Volunteers
- 40 people
- Sponsor
- Outi Aikio