Clinical trials: Premature
Heart Rate Variability, Preterm Infant
Skin to Skin and Heart Rate Variability
The objective of this study is to monitor heart rate variability in preterm infants receiving respiratory support, including conventional mechanical ventilation, during skin-to-skin care.
- Trial name
- NCT05018910
- Testing
- Skin to Skin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of New Mexico
Apnea of Prematurity
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal…
- Trial name
- NCT03298035
- Testing
- NCPAP as mode for apnea prevention, NIPPV as rescue mode for apnea prevention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
Intraventricular Hemorrhage of Prematurity
Tortle Midliner and Intraventricular Hemorrhage
The purpose of the study is to determine if early application of the Tortle Midliner for preterm infants, ≤ 3 hours following birth and with subsequent continuous use through 72 hrs.
- Trial name
- IVH (NCT03543046)
- Testing
- Tortle Midliner
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Orlando Health, Inc.
Bacteria Infection, Respiratory Tract Infections
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection…
- Trial name
- NCT00599053
- Testing
- Azithromycin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- University of Alabama at Birmingham
Preterm Birth
Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of…
- Trial name
- PROLONG (NCT01004029)
- Testing
- Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL, Vehicle
- Where
- 104 sites in United States, Bulgaria and 7 more
- Volunteers
- 1,740 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Pain, Retinopathy of Prematurity
Proparacaine and Mydriatic Eye Drops
In this study, we will be evaluating whether premedication with an anesthetic eye drops leads to a decreased sensation of pain when given dilating eye drops prior to eye examinations to evaluate for retinopathy of prematurity in…
- Trial name
- NCT01266824
- Testing
- Proparacaine Hydrochloride Ophthalmic Solution
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Children's Hospital of Philadelphia
Preterm Delivery, Inadequate Milk Production
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Induction and support of lactation in women with preterm delivery and inadequate milk production.
- Trial name
- MERMAID (NCT02545127)
- Testing
- Merotocin
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Ferring Pharmaceuticals
Heart Failure
Premature Fatigue in Veterans With Heart Failure: Neuronal Influences
A hallmark of patients with heart failure (HF) is premature fatigue which impairs their quality of life and depicts a major source of morbidity.
- Trial name
- NCT02209610
- Testing
- Electrical and Magnetic Nerve Stimulators, Intrathecal Fentanyl
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Retinopathy of Prematurity
Omega-3 Long Chain Polyunsaturated Fatty Acid (LCPUFA) Supplementation in Very Low Birth Weight Infants for The Prevention Retinopathy of Prematurity
Retinopathy of prematurity (ROP) is a blinding disease affecting infants born prematurely. These infants do not have enough essential fatty acids to structurally support the retina, the nerve tissue in the eye which allows us to…
- Trial name
- NCT02486042
- Testing
- Omegaven, Standard lipids (primarily omega-6 fatty acids)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of California, San Diego
Infant,Premature
Improving Right Ventricular Function in Young Adults Born Preterm
The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.
- Trial name
- NCT03696758
- Testing
- Pulmonary Function Testing, Electrocardiogram, Cardiac Magnetic Resonance Imaging
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Wisconsin, Madison
Premature Birth
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth.
- Trial name
- ASPIRIN (NCT02409680)
- Testing
- Low dose aspirin
- Where
- 14 sites in United States, Democratic Republic of the Congo and 5 more
- Volunteers
- 11,976 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Hypothermia
Neonatal Warming to Prevent Hypothermia
Researchers are proposing a pilot randomized controlled trial evaluating the benefit of immediately warming preterm babies using a warming mattress and a plastic wrap, while delaying clamping the umbilical cord at the time of…
- Trial name
- NCT04827394
- Testing
- Neonatal warming mattress, Sterile polyethylene wrap
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- University of Oklahoma
Bronchopulmonary Dysplasia
A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD
A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).
- Trial name
- NCT03857841
- Testing
- UNEX-42, Phosphate-buffered saline
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- United Therapeutics
Preterm Infant
Trial to Improve Multisensory Neural Processing, Language & Motor Outcomes in Preterm Infants
Every year, almost all of ½ million infants born prematurely in the US and 15 million worldwide suffer from abnormal brain maturation resulting from interactions between immaturity and atypical sensory experiences after birth.
- Trial name
- NCT03232931
- Testing
- Therapist skin-to-skin Care, Contingent parent's voice exposure, Parental skin-to-skin care
- Where
- 3 sites in United States
- Volunteers
- 248 people
- Sponsor
- Emory University
Docosohexaenoic Acid Supplementation of Mothers to
DHA Supplementation for Lactating Mothers
The purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function.
- Trial name
- DHA-1 (NCT01732874)
- Testing
- Expecta 200 mg, Expecta 1 gram
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Primary Ovarian Insufficiency, Premature Ovarian Failure
The Impact of Granulocyte Colony Stimulating Factor on Premature Ovarian Insufficiency
The goal of this pilot study is to improve ovarian reserve markers in patients with premature ovarian insufficiency. The main question it aims to answer is: Will treatment with G-CSF allow improvement in markers of ovarian…
- Trial name
- NCT06117982
- Testing
- Neupogen
- Where
- Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Trio Fertility
Preterm Birth, Health Care Utilization
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before…
- Conditions
- Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage
- Trial name
- NCT05120843
- Testing
- Care coordination and motivational interviewing
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Meningitis
Lumbar Punctures in Neonates: Improving Success Rates and Minimizing Pain
The purpose of this study is to compare two medications used to numb an infant's back when performing a lumbar puncture. A lumbar puncture (LP) is often needed in newborns to obtain cerebrospinal fluid (CSF).
- Trial name
- NCT01606150
- Testing
- 1% lidocaine, topical lidocaine
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Georgetown University
Respiratory Syncytial Virus Infections
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
The purpose of this study was to evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of suptavumab (REGN2222) in infants born no more than 35 weeks, 6 days gestational age who are no more than 6 months of age…
- Trial name
- NCT02325791
- Testing
- Suptavumab 30 mg/kg, Suptavumab 30 mg/kg- 1 Dose, Suptavumab 30 mg/kg - 2 Doses
- Where
- 205 sites in United States, Australia and 17 more
- Volunteers
- 1,177 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals