Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004778
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Evaluate the effect of thyrotropin-releasing hormone TRH on the severity of initial lung disease and occurrence of chronic lung disease when given antenatally to women with threatened premature delivery
II Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease
III Investigate whether a deficiency in endogenous cortisol andor thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease
II Evaluate possible mechanisms for the effects of TRH on the severity and incidence of chronic lung disease
III Investigate whether a deficiency in endogenous cortisol andor thyroid hormones after birth influences the severity of lung disease and the development of chronic lung disease
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Participants are stratified by participating institution
Participants are randomly assigned to 1 of 2 treatment groups The first group is treated with intravenous thyrotropin-releasing hormone TRH and intramuscular injections of betamethasone or dexamethasone The second group receives a placebo in place of TRH
Postnatal therapy with surfactants prophylactic steroids and indomethacin is allowed
Participants are randomly assigned to 1 of 2 treatment groups The first group is treated with intravenous thyrotropin-releasing hormone TRH and intramuscular injections of betamethasone or dexamethasone The second group receives a placebo in place of TRH
Postnatal therapy with surfactants prophylactic steroids and indomethacin is allowed
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHP-92536 | None | None | None |