Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239512
Status:
TERMINATED
Last Update Posted:
2006-06-26
First Post:
2005-10-14
Brief Title:
New Management Strategy of PDA for VLBW Preterm Infants
Sponsor:
China Medical University Hospital
Organization:
China Medical University Hospital
Study Overview
Official Title:
New Management Strategy of PDA for VLBW Preterm--Comparison of Indomethacin and Ibuprofen
Status:
TERMINATED
Status Verified Date:
2006-06
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:
Patent ductus arteriosus PDA is one of the most common complications in premature infants Successful pharmacological closure of PDA with indomethacin was first reported in 1976 Since then indomethacin treatment has become the standard or prophylactic treatment for clinically significant PDA in premature infants Clinically there is a high incidence of complications associated with indomethacin treatment including hypoglycemia necrotizing enterocolitis GI bleeding extension of IVH More recently ibuprofen has been shown to be effective for the closure of patent ductus arteriosus in premature infants without reducing mesenteric renal or cerebral blood flowIbuprofen has been shown to close the ductus in animals without reducing cerebralintestinal or renal blood flow Furthermore ibuprofen enhanced cerebral blood-flow autoregulation and had some neuroprotective effect In recent years our strategy of PDA treatment for ELBW infants was essentially early targeted indomethacine treatment depending on echocardiographic shunt flow pattern of PDA Arch Dis Child 199777F36-F40 Acta Paediatr Tw 19983933-7 and Arch Dis Child 199979 F197-F200 By this regimen infants will be eligible for the study if their birth weight less than 1000 gm and if they had PDA without other structured cardiac anomaly confirmed by echocardiography shortly after birth as close as possible to12 hours After parental informed consent is obtained infants will be randomly assigned to two groups based on a double-blined design INDO group will receive echocardiographic assessment at interval of 12-24 hours or clinically necessary and if the PDA had pulsatile or growing flow pattern indomethacin is given if the PDA had flow patterns other than growing or pulsatile pattern no treatment is given The subsequent dose of indomethacin is according to the echocardiographic flow patterns at interval of 24 hours from the last dose When indomethacin was fail to close after the first course the second course of another 3 doses of indomethacin or ibuprofen will be given In spite of infants of INDO group or IBUO group if PDA fail to close after 2 courses of treatment surgical ligation of PDA would be considered according to the infants clinical condition Our historical data showed that the incidence of complication was about 30 Permitting 5 chance of type I error and 20 of type II error and an absolute reduction of the incidence by 20 30 infants in each group is needed to detect a difference Primary outcome of the assessment is the closure rate of PDA and the incidence of death or pulmonary hemorrhage Secondary outcome is IVH or PVL NEC oliguria and CLD We expect that by using this treatment regimen a high PDA closure rate can be achieved and the survival of very premature infants may be increased
Detailed Description:
Patent ductus arteriosus PDA continues to be one of the most common problems in premature infants Delayed closure of PDA can impaired renal function with oligouriaThe complications are correlated with the serum concentration of indomethacin because the safe therapeutic range of serum concentration of indomethacin is very narrow Therefore if we could try another way such as Ibuprofen to close the PDA then we can prevent more complications from indomethacin We expect that by using this treatment regimen according to the echocardiographic flow patterns a high PDA closure rate can be achieved and the survival of premature infants may be increased
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None