Clinical trials: Preterm Neonates
Retinopathy of Prematurity, Pain
The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination
Although screening exams for retinopathy of prematurity (ROP) prevent blindness they are physiologically stressful for infants. The investigators postulate that photosensitivity during mydriasis contributes to post-examination…
- Conditions
- Retinopathy of Prematurity, Pain, Premature Infant, Retinal Disease
- Trial name
- MASK-ROP (NCT03824782)
- Testing
- Phototherapy Mask
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- Sunnybrook Health Sciences Centre
Premature Birth, Obstetric Labor, Premature
Family Nurture Intervention in the NICU
The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal…
- Trial name
- NCT02710474
- Testing
- Family Nurture Intervention, Standard Care
- Where
- 2 sites in United States
- Volunteers
- 461 people
- Sponsor
- Columbia University
Respiratory Distress Syndrome In Premature Infants, Bronchopulmonary Dysplasia
High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance.
Background Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending…
- Conditions
- Respiratory Distress Syndrome In Premature Infants, Bronchopulmonary Dysplasia, Ventilator-Induced Lung Injury, Functional Residual Capacity
- Trial name
- NCT01962818
- Testing
- HFOV combined with sigh breaths
- Where
- Australia
- Volunteers
- 16 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Mother-Infant Interaction
Response of Preterm Infants to Multisensory Stimuli
The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of premature neonates and their mother after sensorial stimuli.
- Trial name
- OXYVOICE (NCT04665440)
- Testing
- Voice alone, Voice + tactile stimuli
- Where
- Switzerland
- Volunteers
- 28 people
- Sponsor
- University Hospital, Geneva
Bronchopulmonary Dysplasia
PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates
There is increasing evidence linking a fetal and early neonatal systemic inflammatory response syndrome to the subsequent development of bronchopulmonary dysplasia (BPD) and white matter injury (WMI) in very preterm infants.
- Trial name
- PREMILOC (NCT00623740)
- Testing
- hydrocortisone
- Where
- France
- Volunteers
- 523 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Apnea, Infant, Premature
Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.
Very premature infants uniformly do not have mature functioning lungs to breathe well nor mature regulation mechanisms to breathe regularly. Assistance with a mechanical respirator is common.
- Conditions
- Apnea, Infant, Premature, Bronchopulmonary Dysplasia
- Trial name
- NCT00188968
- Testing
- Nasal Continuous Positive Airway Pressure, Synchronized Nasal Positive Pressure Ventilation
- Where
- 2 sites in Canada
- Volunteers
- 48 people
- Sponsor
- University of Manitoba
White Matter Injury, Brain Injury, Fetus and Neonate
Neonatal White Matter Injury Trial (WRAP)
The researchers are investigating a new treatment for white matter injury, which is a common type of brain injury in premature babies. The drug, clemastine, is experimental.
- Conditions
- White Matter Injury, Brain Injury, Fetus and Neonate, Neonatal Brain Injury, Periventricular Leukomalacia
- Trial name
- WRAP (NCT07688746)
- Testing
- Clemastine fumarate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Bridget LaMonica Ostrem, M.D., Ph.D.
Bronchopulmonary Dysplasia (BPD)
Impact of the Early Life Virome Development on Bronchopulmonary Dysplasia in Preterm Neonates
Bronchopulmonary dysplasia (BPD) is the most frequent respiratory complication in extremely preterm infants. It leads to significant mortality and long-term morbidity.
- Trial name
- ELVIRE (NCT07487259)
- Testing
- Viral metagenomics and metatranscriptomics analysis of oropharyngeal and stool samples
- Volunteers
- 40 people
- Sponsor
- Hospices Civils de Lyon
Preterm Infant, Placental Insufficiency
Effect of Delayed Cord Clamping in Preterm Neonates With Placental Insufficiency
To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age…
- Conditions
- Preterm Infant, Placental Insufficiency, Placental Transfusion
- Trial name
- NCT03731546
- Testing
- Delayed cord clamping
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Mansoura University Children Hospital
Bronchopulmonary Dysplasia
Fluid Filled Lung Oxygenation Assistance Trial
The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).
- Trial name
- FFLOAT (NCT03041740)
- Testing
- Perfluorooctyl Bromide
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Children's Hospital of Philadelphia
Feeding Difficulties, Sucking Behavior
Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
This study compares three approaches to help premature babies learn to feed by mouth: a special mouth exercise program (called PIOMI), using a pacifier, and standard care.
- Conditions
- Feeding Difficulties, Sucking Behavior, Premature
- Trial name
- PIOMI (NCT07460089)
- Testing
- Premature Infant Oral Motor Intervention (PIOMI), Pacifier Use (Non-Nutritive Sucking)
- Where
- Iraq
- Volunteers
- 150 people
- Sponsor
- University of Baghdad
Bacterial Infections
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
- Trial name
- NCT02688790
- Testing
- Dalbavancin
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- AbbVie
Prematurity, Neonatal Screening
Amino Acid and Acylcarnitine Profiles in Premature Neonates
Primary Hypotheses of the study include: Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness Metabolic profiles differ between neonates who receive…
- Conditions
- Prematurity, Neonatal Screening, Parenteral Nutrition
- Trial name
- NCT00865150
- Where
- 2 sites in United States
- Volunteers
- 1,003 people, healthy volunteers welcome
- Sponsor
- Pediatrix
Weight Gain
Effect of Olive Oil Massage on Growth in Preterm Low Birth Weight Neonate: A Randomized Controlled Clinical Trial
STUDY TITLE: Effect of olive oil massage on growth of preterm low birth weight neonate: A randomized controlled clinical trial." SUMMARY: Preterm low birth weight (LBW) babies have more the risk of the neurological complications…
- Trial name
- NCT05944991
- Testing
- Olive oil message
- Where
- Bangladesh
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Respiratory Distress Syndrom, High Flow Nasal Cannula
Efficacy and Tolerance of High Flow Nasal Cannula for Respiratory Distress Syndrom in Late Preterms (34-36 Weeks)
The main objective of the study is to gather preliminary data on the effectiveness of High Flow Nasal canula (HFNC), provided since the delivery room, for ventilatory support in newborns of 34-36 weeks with moderate respiratory…
- Trial name
- PRIMAIR (NCT02958488)
- Testing
- High Flow Nasal Cannula
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Montpellier
Premature Newborn
Reproducibility of a New Practical Newborn Behavioral Observation Scale
Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care.
- Trial name
- NCT02844205
- Testing
- quotation of the newborn behavioral observation scale
- Where
- France
- Volunteers
- 10 people
- Sponsor
- University Hospital, Montpellier
Transient Tachypnea of the Newborn
Role of Salbutamol and Furosemide in TTN
to see the effects of slabutamol and IV furosemide in the treatment of transient tachypnea of newborn
- Trial name
- NCT03208894
- Testing
- Furosemide Injection
- Where
- 2 sites in Pakistan
- Volunteers
- 100 people
- Sponsor
- Armed Forces Hospital, Pakistan
Preterm Infants
Perenteral Nutrition and Oxidative Stress in Preterm Infants
In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined different strategies such as photo-protection, adding multivitamins to the lipid emulsion rather than to the dextrose-amino acid…
- Trial name
- NCT00611546
- Testing
- Photo-protection, Photo-exposure
- Volunteers
- 80 people
- Sponsor
- Mansoura University
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Bronchopulmonary Dysplasia, Preterm
Body Weight Growth After Birth and Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967…
- Trial name
- NCT05053269
- Testing
- good body weight growth, poor body weight growth
- Where
- China
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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