Clinical trials: Gestational Age
Extremely Low Gestational Age Newborn, Premature Infant
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants.
- Trial name
- NCT01536093
- Testing
- oropharyngeal administration of own mother's colostrum, oropharyngeal administration of sterile water
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Sleep, Pregnancy
Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth
Every day in Ghana, 47 babies are stillborn (SB) and 232 babies are born with low birth-weight (LBW) - many of whom will die in infancy or suffer lifelong consequences.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02379728
- Testing
- PrenaBelt, Body Position Sensor
- Where
- Ghana
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Allan Kember
SGA, Turner Syndrome
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature.
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Trial name
- REAL 9 (NCT05723835)
- Testing
- Somapacitan
- Where
- 18 sites in United States, Malaysia and 4 more
- Volunteers
- 47 people
- Sponsor
- Novo Nordisk A/S
Preterm Infant, Oral Feeding Performance
Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants
The objective of this study is to evaluate the efficacy of an oral stimulation program on the length of the transition period in preterm infants (primary outcome), the length of hospital stay and the breastfeeding rates at…
- Trial name
- NCT01649362
- Testing
- prefeeding oral stimulation program
- Where
- Luxembourg
- Volunteers
- 101 people
- Sponsor
- Centre Hospitalier du Luxembourg
Infant, Small for Gestational Age
Genotropin Treatment In Very Young Children Born Small For Gestational Age
To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.
- Trial name
- EGN (NCT00627523)
- Testing
- Genotropin (PN-180,307) Somatropin, Control-no treatment
- Where
- 17 sites in Belgium, Czechia and 7 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
Infant, Small for Gestational Age, Infant, Low Birth Weight
KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help…
- Conditions
- Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy, Sleep
- Trial name
- KBTH-HBWS (NCT03062228)
- Where
- Ghana
- Volunteers
- 162 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre
Gestational Diabetes, Pregnancy
Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes.
- Conditions
- Gestational Diabetes, Pregnancy, Glucose Intolerance
- Trial name
- GDM2 (NCT02309138)
- Testing
- Gestational diabetes screening with fasting 3 hour 100 gm, Gestational diabetes screening with fasting 2 hour 75g
- Where
- United States
- Volunteers
- 921 people, healthy volunteers welcome
- Sponsor
- Esa M Davis, MD MPH FAAFP
Respiratory Distress Syndrome
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal…
- Trial name
- NCT02636868
- Testing
- Lucinactant delivered via investigational delivery device, nCPAP
- Where
- 54 sites in United States, Canada and 6 more
- Volunteers
- 221 people
- Sponsor
- Windtree Therapeutics
Infant, Newborn, Hypoxia, Brain
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
This study is a randomized, placebo-controlled, clinical trial to evaluate whether induced whole-body hypothermia initiated between 6-24 hours of age and continued for 96 hours in infants ≥ 36 weeks gestational age with…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT00614744
- Testing
- Hypothermia, Normothermic Control
- Where
- 22 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Postpartum Depression, Small for Gestational Age at Delivery
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
In the proposed study the investigators will develop an early prenatal preventive intervention targeting anxiety and conduct a randomized controlled trial in Pakistan to test its efficacy in reducing generalized anxiety disorder…
- Conditions
- Postpartum Depression, Small for Gestational Age at Delivery, Preterm Birth, Anxiety
- Trial name
- HMHB (NCT03880032)
- Testing
- Cognitive Behavioral Therapy Intervention for Anxiety
- Where
- Pakistan
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Infant, Newborn, Diseases, Other Preterm Infants
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for premature infants born at 24…
- Conditions
- Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth
- Trial name
- SUPPORT (NCT00233324)
- Testing
- Surfactant, Continuous Positive Airway Pressure (CPAP), Supplemental oxygen with target saturation of 85 to 89%
- Where
- 22 sites in United States
- Volunteers
- 1,316 people
- Sponsor
- NICHD Neonatal Research Network
Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or
Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season
This is a Phase 2, randomized, double-blind study in which motavizumab (MEDI-524) and palivizumab were administered sequentially to high-risk children during the same respiratory syncytial virus (RSV) season.
- Conditions
- Respiratory Syncytial Virus Infections, Chronic Lung Disease and <= 24 Months of Age or, Premature With Gestational Age <=35 Weeks and <=6 Months of Age
- Trial name
- NCT00316264
- Testing
- Motavizumab, palivizumab, Palivizumab, motavizumab, Motavizumab
- Where
- 19 sites in Australia, Chile and 1 more
- Volunteers
- 260 people
- Sponsor
- MedImmune LLC
Infant, Newborn, Infant, Low Birth Weight
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- NEST (NCT01029353)
- Testing
- Laparotomy, Drainage
- Where
- 22 sites in United States
- Volunteers
- 529 people
- Sponsor
- NICHD Neonatal Research Network
Foetal Growth Problem, Small for Gestational Age
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.
- Trial name
- NCT00184717
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 98 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Therapy, Infant, Very Low Birth Weight
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Trial name
- AGA (NCT00174460)
- Testing
- Somatropin, Control Arm
- Where
- 8 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Pfizer
Complication Due to Immunization
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Background: Inflammation may depress respiration in neonates. The aim of this study was to establish a link between post-immunization inflammation and cardio-respiratory events (CRE).
- Trial name
- NCT02726178
- Testing
- Advil® Pediatric drops for infants
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- St. Justine's Hospital
Sleep, Pregnancy
Halifax PrenaBelt Trial
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02377817
- Testing
- PrenaBelt
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Infant, Small for Gestational Age
A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)
This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.
- Trial name
- SAIZEN in SGA (NCT01067352)
- Testing
- Recombinant human growth hormone (r-hGH)
- Where
- Italy
- Volunteers
- 25 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Short Stature Born Small for Gestational Age (SGA)
Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)
To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.
- Trial name
- NCT01859949
- Testing
- Genotropin (somatropin)
- Where
- 19 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Pfizer
Bronchopulmonary Dysplasia (BPD)
Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial
This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.
- Trial name
- SASSIE (NCT02907593)
- Testing
- Budesonide in Calfactant
- Where
- 5 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cynthia McEvoy