Clinical trials: Gestational Age
Infant, Small for Gestational Age
Safety Study In Patients Who Were Born Small And Short And Were Treated With Growth Hormone To Achieve Normal Height
The purpose of this study is to demonstrate that insulin sensitivity is not different between growth hormone - treated subjects who are small for gestational age (SGA) and an SGA cohort of subjects matched by gender and body mass…
- Trial name
- NCT00396474
- Testing
- post GH treatment observational study
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Pulmonary Hypertension, Hypoxic Respiratory Failure
Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
This is a prospective, open-label, single-arm, multicenter Phase IV clinical study to evaluate the safety of INOmax for the treatment of hypoxic respiratory failure with pulmonary hypertension in newborns (≥ 34 weeks gestational…
- Trial name
- INOFTTONHRFWPH (NCT07099144)
- Testing
- Inhaled nitric oxide (NO)
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Lee's Pharmaceutical Limited
Children Born With Serious Intra-uterine Growth Retardation
Saizen in Intra-uterine Growth Retardation
Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France.
- Trial name
- NCT01400698
- Testing
- Saizen® A, Saizen® B, Observation only
- Volunteers
- 91 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Foetal Growth Problem, Small for Gestational Age
Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction
This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.
- Trial name
- NCT00519844
- Testing
- somatropin
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Observational Prospective Study on Patients Treated With Norditropin®
This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Adult Growth Hormone Deficiency, Genetic Disorder
- Trial name
- NCT00960128
- Testing
- somatropin
- Where
- 23 sites in Argentina, Belgium and 21 more
- Volunteers
- 21,249 people
- Sponsor
- Novo Nordisk A/S
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 Children Born Small for Gestational Age (SGA)
Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature
The study was evaluated as the optimal dose for the treatment of SGA short stature children by Pegylated Somatropin, initially evaluated its efficiency and safety for the treatment of SGA short stature children and provided…
- Trial name
- NCT02375620
- Testing
- PEG-somatropin
- Where
- 9 sites in China
- Volunteers
- 96 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Growth Hormone Therapy, Infant, Small for Gestational Age
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
- Trial name
- SGA-POWER (NCT00625872)
- Testing
- Somatropin
- Where
- 10 sites in Germany
- Volunteers
- 23 people
- Sponsor
- Pfizer
Small for Gestational Age Infant
A Study of Recombinant Human Growth Hormone Injection（JINTOPIN AQ）for Short Children With Small for SGA
To preliminary assess the efficacy and safety of recombinant human growth hormone injection on the treatment of small for gestational age (SGA), and determine the best dose.
- Trial name
- NCT03221933
- Testing
- Somatropin Injection low dose group, Somatropin Injection high dose group
- Where
- 5 sites in China
- Volunteers
- 120 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
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
Growth Hormone Deficiency, Turner Syndrome
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age
- Trial name
- NCT00738205
- Volunteers
- 834 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Growth Hormone Deficiency, Turner Syndrome
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal…
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age
- Trial name
- LGS (NCT01604395)
- Where
- South Korea
- Volunteers
- 6,000 people
- Sponsor
- LG Chem
Congenital Cytomegalovirus Infection
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
A phase 3, open-label, single-arm, prospective, multi-center trial of Cytotect CP Biotest (BT097) for prevention of maternal-fetal CMV transmission after primary maternal CMV infection.
- Trial name
- PreCyssion (NCT05170269)
- Testing
- BT097
- Where
- 5 sites in Germany
- Volunteers
- 48 people
- Sponsor
- Biotest
Healthy
An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants
The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.
- Trial name
- NCT00983606
- Where
- 222 sites in United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Short Bowel Syndrome
A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older
The main aims of the study are to check for side effects from teduglutide. Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks.
- Trial name
- NCT05027308
- Testing
- Teduglutide
- Where
- 6 sites in Japan
- Volunteers
- 3 people
- Sponsor
- Takeda
Infant, Small for Gestational Age
Growth Hormone Treatment in Short Children Born Small for Gestational Age
Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.
- Trial name
- NCT00191529
- Testing
- somatropin
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Eli Lilly and Company
Prevention of Growth Restriction
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants
The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.
- Trial name
- LAIF (NCT01413581)
- Testing
- rhBSSL (recombinant human bile-salt-stimulated lipase)
- Where
- 49 sites in Belgium, Czechia and 8 more
- Volunteers
- 415 people
- Sponsor
- Swedish Orphan Biovitrum
Cardiac Disease
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment.
- Trial name
- NCT03395639
- Testing
- Edoxaban, Standard of Care (SOC)
- Where
- 48 sites in United States, Austria and 12 more
- Volunteers
- 168 people
- Sponsor
- Daiichi Sankyo
Foetal Growth Problem, Small for Gestational Age
Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.
- Trial name
- NCT00557336
- Testing
- somatropin
- Where
- 37 sites in Spain
- Volunteers
- 160 people
- Sponsor
- Novo Nordisk A/S