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New Management Strategy of PDA for VLBW Preterm Infants

This study has been terminated.
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT00239512
First received: October 14, 2005
Last updated: June 23, 2006
Last verified: June 2006
  Purpose

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 flow.Ibuprofen has been shown to close the ductus in animals without reducing cerebral,intestinal 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 1997;77:F36-F40. Acta Paediatr Tw 1998;39:33-7. and Arch Dis Child 1999;79: 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 infant’s 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.


Condition Intervention
Ductus Arteriosus, Patent
Preterm Infants
Drug: Indomethacin and Ibuprofen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: New Management Strategy of PDA for VLBW Preterm--Comparison of Indomethacin and Ibuprofen

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Primary outcome of the assessment is the closure rate of PDA and the incidence of death or pulmonary hemorrhage.

Secondary Outcome Measures:
  • Secondary outcome is IVH or PVL, NEC, oliguria and CLD.

Estimated Enrollment: 60
Study Start Date: March 2005
Estimated Study Completion Date: June 2006
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 oligouria.The 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.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Premature infants with birth weight < 1000 gm
  2. Premature infants with RDS required IMV
  3. Echocardiographic evidence of PDA within 12 hours after birth

Exclusion Criteria:

Presence of prenatal infection, congenital anomalities and lethal cardiopulmonary status

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239512

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404-08
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Tsu-Fuh Yeh, MD China Medical University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00239512     History of Changes
Other Study ID Numbers: DMR94-IRB-13
Study First Received: October 14, 2005
Last Updated: June 23, 2006
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
PDA
VLBW infants
Indomethacin
Ibuprofen

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Ibuprofen
Indomethacin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 20, 2014