Clinical trials: Labor and Delivery Complication
Premature Birth
Fathers and Late Preterm Babies Study
The purpose of this study is to test an educational intervention for first-time fathers of late preterm (34 to 36 weeks gestation) infants.
- Trial name
- FLPTB (NCT01056653)
- Testing
- Standard Dose, High Dose, Comparison Group
- Where
- Canada
- Volunteers
- 113 people
- Sponsor
- University of Calgary
Intraventricular Haemorrhage Neonatal, Death; Neonatal
Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns.
- Trial name
- PREMOD2 (NCT03019367)
- Testing
- Umbilical cord milking UCM, Delayed cord clamping DCC
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 1,201 people
- Sponsor
- Sharp HealthCare
Infant Development, Infant,Premature
Pacifier Activated Device and Mother's Voice in Infants at High-risk for Cerebral Palsy
The study seeks to determine the efficacy of non-nutritive suck (NNS) training using a pacifier-activated device (PAM) with mothers' voice to condition suck-strength and rhythmicity, in improving the feeding and developmental…
- Conditions
- Infant Development, Infant,Premature, Hydrocephalus, Neonatal Encephalopathy
- Trial name
- NCT03230032
- Testing
- pacifier-activated device
- Where
- United States
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Premature Infant, Mother-Baby Synchrony
Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
Observations of the early interactions between the infant and his parents highlighted the existence of rhythmic and reciprocal communications that serve as a basis for the mother-baby relationship and the emotional and cognitive…
- Trial name
- SynchroPrema (NCT03114644)
- Testing
- Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Infant, Newborn, Infant, Low Birth Weight
Delayed Cord Clamping in VLBW Infants
This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NCT01222364
- Testing
- Standard Cord Clamping, Delayed Cord Clamping
- Where
- 4 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network
Preterm Birth
Oral Entrainment on Suck Development of Preterm Infants Born 23 to 34 Weeks Gestational Age (GA)
The development of sucking behaviors in preterm infants is thought to reflect neurobehavioral maturation and organization. From a clinical perspective, the ability to feed depends upon a coordinated sucking, swallowing and…
- Trial name
- NCT01069744
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- KC BioMediX, Inc
Bronchopulmonary Dysplasia, Preterm Infant Development
PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants
The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks.
- Conditions
- Bronchopulmonary Dysplasia, Preterm Infant Development, Asthma Childhood, Bronchiolitis
- Trial name
- PremaBiom (NCT07411261)
- Testing
- Nasal swab, blood sampling, Mother milk sampling
- Where
- 6 sites in France
- Volunteers
- 270 people
- Sponsor
- University Hospital, Caen
Preterm Birth, Mother-Infant Interaction
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants.
- Conditions
- Preterm Birth, Mother-Infant Interaction, Infant Development
- Trial name
- COSY (NCT05975203)
- Testing
- skin-to-skin contact
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University of Cologne
Premature Infants
A Randomized Trial of Outpatient Oxygen Weaning Strategies in Premature Infants
The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management…
- Trial name
- NCT01994954
- Testing
- RHO
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- University of Massachusetts, Worcester
Hypoxia, Brain, Premature Birth
PREMOD2 With Near Infrared Spectroscopy Sub-study
Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown.
- Trial name
- PREMOD2 (NCT03145142)
- Testing
- Umbilical cord milking, Delayed Cord Clamping
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 121 people
- Sponsor
- Sharp HealthCare
Neonatal Resuscitation, Apnea Neonatal
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method.
- Trial name
- MVP (NCT06849596)
- Testing
- Ventilator derived positive pressure ventilation - V-PPV, T-piece resuscitator (TPR)
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 780 people
- Sponsor
- Michelle Baczynski
Preterm Birth
Atosiban Versus Placebo in the Treatment of Late Threatened Pre-term Birth
The aim of this study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.
- Trial name
- APOSTEL 8 (NCT05693688)
- Testing
- Atosiban
- Where
- Netherlands
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Premature Infant
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
Out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. The pain is often under estimated due to the frequency with which the procedure is carried out.
- Trial name
- PAPS (NCT03939169)
- Testing
- Installation of a naso-gastric feeding tube
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Infant, Preterm, Respiratory Distress Syndrome (Neonatal)
Pulmonary Volume Changes During Synchonized Noninvasive Positive Pressure Ventilation
Current evidence suggests that noninvasive positive pressure ventilation (NIPPV) is more effective than continuous positive airway pressure (CPAP) in preventing respiratory failure in preterm infants with respiratory distress…
- Conditions
- Infant, Preterm, Respiratory Distress Syndrome (Neonatal), Chronic Lung Disease of Newborn, Respiratory Support
- Trial name
- INSPIRE (NCT07237139)
- Testing
- Electrical Impedance Tomography (EIT)
- Where
- Switzerland
- Volunteers
- 27 people
- Sponsor
- University of Zurich
Intrauterine Growth Retardation (IUGR), Lung Function Tests
Early Lung Function Trajectories: Comparison Between Infants With and Without Intrauterine Growth Restriction.
During intrauterine life, some babies are smaller or grow less than expected. This fetal growth abnormality, called fetal growth restriction (FGR), can be diagnosed by ultrasound.
- Conditions
- Intrauterine Growth Retardation (IUGR), Lung Function Tests, Preterm Infant, Respiratory Monitoring
- Trial name
- ELFIGO (NCT06919757)
- Testing
- fetal ultrasound to assess lungs, heart and diaphragm
- Where
- Italy
- Volunteers
- 54 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Premature Infants
Clinical Experience With Numeta in Preterm Infants
The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition.
- Trial name
- Numeta (NCT01981057)
- Testing
- Numeta, Individual
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Infant, Premature
Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability…
- Trial name
- Pre-Vent (NCT03174301)
- Where
- United States
- Volunteers
- 739 people
- Sponsor
- University of Virginia
Postpartum Hemorrhage, Neonatal Asphyxia
Saving Lives at Birth in Uganda: Building and Sustaining Capacity of Frontline Health Workers - A Program Evaluation
The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and…
- Trial name
- NCT03254628
- Testing
- Helping Mothers Survive - Bleeding After Birth training, Helping Babies Breathe, Mentor
- Volunteers
- 3,440 people
- Sponsor
- Jhpiego
Infant, Premature
Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea
Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal…
- Trial name
- COLOSTRUM (NCT02650167)
- Testing
- Colostrum feeding, formula for preterm infants
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Premature Infant, Oxygen Therapy
Servo Controlled Oxygen Targeting Study
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is…
- Conditions
- Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia
- Trial name
- SCO2T (NCT04177992)
- Testing
- Servo control
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- University of Edinburgh
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