Clinical trials: 28 Weeks of Gestation
Perinatal Mortality, Premature Rupture of Fetal Membranes
Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation
Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation.
- Trial name
- PPROM (NCT03108404)
- Testing
- Validation of a diagnostic test
- Where
- France
- Volunteers
- 34 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Premature Birth
E-23596 - Use of NCPAP Cycling to Wean Preterm Infants
Objective: To compare the effectiveness of nasal continuous positive airway pressure (NCPAP) cycling to continuous NCPAP in successful weaning of preterm infants of 25-28 weeks gestation to nasal prongs.
- Trial name
- NCT02114112
- Testing
- NCPAP cycling, NCPAP continuous
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University of Calgary
Transient Tachypnea of the Newborn, TTN
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.
- Conditions
- Transient Tachypnea of the Newborn, TTN, Respiratory Distress Syndrome, RDS
- Trial name
- NCT01517958
- Testing
- Respiratory Distress Group, Control Group
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Respiratory Distress Syndrome, Newborn
Amniotic Fluid Optical Density Determination as a Test for Assessment of Fetal Lung Maturity.
To determine the relationship between the result of amniotic fluid optical density between 26 and 36 6/7 weeks of pregnancy and the risk of developing neonatal respiratory distress syndrome.
- Trial name
- NCT02332304
- Testing
- Preterm fetus
- Where
- Panama
- Volunteers
- 200 people
- Sponsor
- Saint Thomas Hospital, Panama
Anesthesia
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks…
- Trial name
- NCT01508455
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Prematurity Complications, Neurodevelopment Outcome
Antenatal vs Postnatal Transport Team Positioning in Extremely Preterm Outborn Infants
The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births…
- Conditions
- Prematurity Complications, Neurodevelopment Outcome, Prematurity
- Trial name
- OutbornTRANSF (NCT07580859)
- Testing
- Usual Care
- Where
- France
- Volunteers
- 627 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Vitamin D Deficiency
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of…
- Trial name
- NCT05694689
- Testing
- 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth, Usual Care
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- The University of Texas Health Science Center, Houston
Respiration; Insufficient or Poor, Newborn, Infant, Premature, Diseases
Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment…
- Trial name
- CORSAD (NCT02563717)
- Testing
- T-piece used for respiratory support (several manufacturers), New system used for respiratory support
- Where
- 6 sites in Iceland, Lithuania and 3 more
- Volunteers
- 250 people
- Sponsor
- Baldvin Jonsson
Intrauterine Fetal Demise
Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy
The purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of…
- Trial name
- NCT00671060
- Testing
- Misoprostol
- Where
- 5 sites in United States, Vietnam
- Volunteers
- 153 people
- Sponsor
- Gynuity Health Projects
Prematurity, Respiratory Distress Syndrome, Newborn
Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
In Canada each year, there are approximately 800 infants born between 28 and 32 weeks gestation. Up to 60% of these infants will require breathing tube placement for Respiratory Distress Syndrome or RDS.
- Trial name
- OLIVIA (NCT00486395)
- Testing
- CPAP, Mechanical ventilation
- Where
- 6 sites in Canada
- Volunteers
- 126 people
- Sponsor
- Children's & Women's Health Centre of British Columbia
Bronchopulmonary Dysplasia
OPTIMIST-A Trial: Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on CPAP
Trial question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? Trial hypothesis…
- Trial name
- OPTIMIST-A (NCT02140580)
- Testing
- Minimally invasive surfactant therapy, Continuation on CPAP
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 486 people
- Sponsor
- Menzies Institute for Medical Research
Prematurity, Development Delay
Maternal Voice and Quantitative EEG (qEEG)
A short-term randomized, blinded placebo-controlled trial, in premature infants in the neonatal intensive care unit (NICU) at 33-35 weeks post-conceptional age, of recorded maternal voice on quantitative EEG (spectral power…
- Conditions
- Prematurity, Development Delay, Premature Birth
- Trial name
- NCT05391633
- Testing
- Recorded Maternal Voice
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of New Mexico
Premature Brain Oxygenation
Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants
This study is intended to see the effect of Mozart music on oxygen content of brain of premature infants once they achieve corrected gestation of 28-32 weeks and are clinically stable. Each baby is its own control.
- Trial name
- NCT02471482
- Testing
- Mozart music lullaby
- Volunteers
- 30 people
- Sponsor
- Coombe Women and Infants University Hospital
The Gestational Age of the Newborn is Between 28-37 Weeks, Stable Health Status of the Newborn
The Effect of Kangaroo Care and Lullaby on Mother-Baby Physiological Parameters and Mother's State Anxiety Level
This study was planned to investigate the effect of kangaroo care and lullaby on mother-baby physiologic parameters and mother's state anxiety level in premature newborns.
- Conditions
- The Gestational Age of the Newborn is Between 28-37 Weeks, Stable Health Status of the Newborn, Mothers' Willingness to Participate in the Study
- Trial name
- NCT06964204
- Testing
- Kangaroo Care, Kangaroo Care+lullabies
- Where
- Turkey (Türkiye)
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Kirsehir Ahi Evran Universitesi
Resuscitation
Pilot Study to Assess Safety and Feasibility of Resuscitation of Preterm Infants With Controlled Volume of Air/Oxygen
QUESTION: Is controlled tidal volume delivery during the resuscitation of preterm infants < 28 weeks' gestation safe and feasible? BACKGROUND AND RATIONALE: Current resuscitation of preterm neonates follows the Neonatal…
- Trial name
- NCT00157989
- Testing
- Controlled tidal volume resuscitation
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- Mount Sinai Hospital, Canada
Premature Newborns With Gestational Age 28 to 33 Weeks
Odors to Insufflate Life
Apneas concern about 85% of premature newborns (NB) born after less than 34 weeks of pregnancy. They are considered as an important risk factor for subsequent neuropsychological deficiency.
- Trial name
- PREMODEUR (NCT02851979)
- Testing
- Olfactory stimulations
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- Hospices Civils de Lyon
Premature Birth
Skin-to-skin After Delivery in Preterm Infants Born at 28-32 Weeks of Gestation
The aim of the study is to investigate physiological response, social/emotional response and general movements in preterm infants when they are given skin-to-skin contact with the mother (intervention) or standard care…
- Trial name
- NCT02024854
- Testing
- skin-to-skin, standard care
- Where
- 4 sites in Canada, Norway
- Volunteers
- 108 people
- Sponsor
- Norwegian University of Science and Technology
Bronchopulmonary Dysplasia
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube).
- Trial name
- NCT01440647
- Testing
- Extubation to NIPPV, Extubation to CPAP
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Women and Infants Hospital of Rhode Island
Sedation
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading…
- Trial name
- NCT01159262
- Testing
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Where
- 18 sites in United States, Guatemala
- Volunteers
- 36 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Vitamin D Supplementation
Efficacy of Higher Dose Enteral Vitamin D Supplementation in Preterm 28 - 34 Weeks of Gestational Age
The goal of this clinical trial is to learn about the effective dosage of enteral vitamin D supplementation in preterm infants with gestational age fom 28 to 34 weeks.
- Trial name
- NCT06674122
- Testing
- Enteral vitamin D supplementation of 800 IU/day, Enteral vitamin D supplementation of 400 IU/day
- Where
- Indonesia
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia