Clinical trials: Gestational Age
Non-invasive Ventilatory Support, Infant Respiratory Distress Syndrome
Observational Study in Preterm Neonates Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
- Trial name
- NCT01861795
- Testing
- Preterm Neonates
- Where
- 3 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Takeda
Healthy Infants
A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis [DTaP] Hepatitis B [HB] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to…
- Trial name
- NCT01896739
- Testing
- Eutravac
- Where
- 7 sites in South Korea
- Volunteers
- 289 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
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
Small For Gestational Age (SGA)
Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age
The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA).
- Trial name
- GH-RAST (NCT01897753)
- Testing
- growth hormone
- Where
- 12 sites in Spain
- Volunteers
- 264 people
- Sponsor
- Pfizer
Growth Disorders
Treatment Of Children With Short Stature At An Age Of 3-7 Years Who Were Born Small For Gestational Age
The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well.
- Trial name
- NCT00174408
- Testing
- Genotropin
- Volunteers
- 110 people
- Sponsor
- Pfizer
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
Infant, Small for Gestational Age
SURF, Neurodevelopment, Growth Study in SGA Infants
The purpose of this study is to determine whether term SGA infants who are fed a nutrient-enriched pre-term formula will have a higher cognitive score, a more appropriate length-for-age Z-score (leading to a lower prevalence of…
- Trial name
- NCT04360967
- Testing
- Standard Formula, Nutrient-enriched Formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Hyperbilirubinemia, Neonatal Jaundice
Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age
The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and as part of standard of care all hospitalized newborns are routinely monitored for the development of high bilirubin or jaundice every…
- Trial name
- NCT02774434
- Testing
- JM-105
- Where
- 3 sites in Canada
- Volunteers
- 464 people
- Sponsor
- Draeger Medical Systems, Inc.
Foetal Growth Problem, Small for Gestational Age
Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing
This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short…
- Trial name
- NCT01110928
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 227 people
- Sponsor
- Novo Nordisk A/S
Small for Gestational Age (SGA) Infants, Appropriate for Gestational Age (AGA) Infants
An Observational Study to Characterize Human Milk From Mothers Delivering Term SGA and AGA Infants.
This is an observational study to characterize human milk of mothers delivering term SGA and term AGA infants. This is an observational, exploratory, longitudinal (from birth to 6 months postpartum), 4 parallel groups, and…
- Trial name
- NCT02421445
- Where
- 3 sites in India
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Infant Formula for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in infant formula.
- Trial name
- NCT00658905
- Testing
- rhBSSL
- Where
- 6 sites in Italy
- Volunteers
- 33 people
- Sponsor
- Swedish Orphan Biovitrum
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- NCT01245374
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 103 people
- Sponsor
- Novo Nordisk A/S
Small Gestational Age (SGA)
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving…
- Trial name
- SGA OPTIMIS (NCT00249821)
- Testing
- Saizen®
- Volunteers
- 22 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
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Safety and Efficacy of Long-term Somatropin Treatment in Children
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- GrowthWIN II (NCT01543867)
- Testing
- somatropin
- Where
- Germany
- Volunteers
- 5,442 people
- Sponsor
- Novo Nordisk A/S
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
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
Small for Gestational Age (SGA)
Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"
The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).
- Trial name
- NCT01897766
- Testing
- Somatropin
- Volunteers
- 482 people
- Sponsor
- Pfizer