Clinical trials: Birth Injuries
Preterm Birth, Injuries
Nurse-Family Partnership Impact Evaluation in South Carolina
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial.
- Conditions
- Preterm Birth, Injuries, Maternal Behavior
- Trial name
- NFP (NCT03360539)
- Testing
- Nurse-Family Partnership
- Where
- 9 sites in United States
- Volunteers
- 5,670 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Respiratory Syncytial Virus Infection, Premature Birth
Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children
100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial…
- Conditions
- Respiratory Syncytial Virus Infection, Premature Birth, Bronchopulmonary Dysplasia, Congenital Heart Disease
- Trial name
- NCT01006629
- Testing
- palivizumab
- Where
- 19 sites in Russia
- Volunteers
- 100 people
- Sponsor
- Abbott
Neonatal Brachial Plexus Palsy
NMES Efficacy on Patients With NBPP
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm.
- Trial name
- NCT01999465
- Testing
- Standard NMES device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Michigan
Abscess
The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
The purpose of this study was to evaluate the safety and effectiveness of Irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.
- Trial name
- NCT04957732
- Testing
- Standard of Care (SoC), Irrisept Delivery System
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Irrimax Corporation
Cesarean Section
Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples
Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples.
- Trial name
- NCT00524511
- Testing
- Surgical skin staples, Dermabond
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- University of Massachusetts, Worcester
Respiratory Distress Syndrome, Newborn, Premature Birth
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required…
- Conditions
- Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia
- Trial name
- NCT00215540
- Testing
- Lucinactant 175 mg/kg, Lucinactant 90 mg/kg
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Windtree Therapeutics
Infant, Newborn, Infant, Small for Gestational Age
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life.
- Conditions
- Infant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, Premature
- Trial name
- NCT01353313
- Testing
- Hydrocortisone
- Where
- 20 sites in United States
- Volunteers
- 800 people
- Sponsor
- NICHD Neonatal Research Network
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
Prematurity, Bronchopulmonary Dysplasia
Inhaled Nitric Oxide and Neuroprotection in Premature Infants
The purpose of this study is to determine whether inhaled nitric oxide improves the neurological outcome for premature infants.
- Conditions
- Prematurity, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Periventricular Leukomalacia
- Trial name
- NOVA2 (NCT00515281)
- Testing
- inhaled nitric oxide, oxygen
- Where
- United States
- Volunteers
- 273 people
- Sponsor
- University of Chicago
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome
The Budesonide in Babies (BiB) Trial
This is a Phase 3, randomized, masked, active-controlled, multicenter trial designed to determine whether early intratracheal administration of a combination of budesonide with surfactant, as compared to surfactant alone, will…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome, Prematurity; Extreme, Neonatal
- Trial name
- BiB (NCT04545866)
- Testing
- budesonide (Pulmicort nebulizing suspension)., surfactant (poractant alfa;Curosurf)
- Where
- 19 sites in United States
- Volunteers
- 642 people
- Sponsor
- NICHD Neonatal Research Network
Ureaplasma Infections
Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants
The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.
- Trial name
- AZIPIII (NCT01778634)
- Testing
- Azithromycin
- Where
- 7 sites in United States
- Volunteers
- 121 people
- Sponsor
- University of Maryland, Baltimore
Surgical Site Infections
The Skin Prep Study
The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at…
- Trial name
- NCT01472549
- Testing
- Iodine-alcohol, Chlorhexidine-alcohol
- Where
- United States
- Volunteers
- 1,147 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Prematurity, Apnea
Caffeine to Reduce Mechanical Ventilation in Preterm Infants
Most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop Bronchopulmonary Dysplasia (BPD).
- Conditions
- Prematurity, Apnea, Respiratory Failure
- Trial name
- NCT01751724
- Testing
- Caffeine citrate, Normal saline
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- University of Miami
Bronchopulmonary Dysplasia
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated…
- Trial name
- TOLSURF (NCT01022580)
- Testing
- Infasurf surfactant (ONY, Inc.)
- Where
- 21 sites in United States
- Volunteers
- 511 people
- Sponsor
- Roberta Ballard
Acute Kidney Injury, Premature Infant
NIRS Monitoring to Detect AKI in Preterm Infants
This study will examine the relationship of oxygen levels, using Near-infrared spectroscopy (NIRS) monitoring, and kidney injury in infants born prematurely.
- Trial name
- nNIRS-AKI (NCT03384173)
- Testing
- Near Infrared Spectroscopy
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Wisconsin, Madison
Bronchopulmonary Dysplasia
Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants
Bronchopulmonary dysplasia of premature infants is a common respiratory disease in premature infants. Long-term complications such as recurrent respiratory infection and abnormal lung function may occur in the survivors, and may…
- Trial name
- NCT04184648
- Testing
- no interventions
- Where
- China
- Volunteers
- 322 people
- Sponsor
- Wang Jianhui
Pediatric Traumatic Brain Injury
Overcoming Membrane Transporters to Improve CNS Drug Delivery - Improving Brain Antioxidants After Traumatic Brain Injury
The overall purpose of this research study is to investigate the safety of pharmacological therapies that may potentially improve pediatric outcomes after traumatic brain injury.
- Trial name
- Pro-NAC (NCT01322009)
- Testing
- Probenecid and N-acetyl cysteine
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of Pittsburgh
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction), Bronchopulmonary Dysplasia
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
- Trial name
- TOLSURFPilot (NCT00569530)
- Testing
- Infasurf (ONY Inc.)
- Where
- 9 sites in United States
- Volunteers
- 85 people
- Sponsor
- Roberta Ballard