Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494429
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2007-06-28
Brief Title:
Optimizing the Use of Morphine in Pre-Term Neonates
Sponsor:
John van den Anker
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Optimizing Pain Treatment in Pre-Term Neonates
Status:
COMPLETED
Status Verified Date:
2016-07
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:
The purpose of this study is to improve the dosing of morphine in critically ill premature neonates
Detailed Description:
The investigators hypothesize that identifying co-variates predictive of variability in morphine disposition andor response will provide the scientific basis for rationale and individualized morphine dosing schemes in neonates and young infants
60 preterm neonates ranging in gestational age from 22 to 32 weeks will be recruited from the NICU Stratification by gestational age will be done to ensure broad representation The decision to initiate morphine therapy will be based solely on clinical indications Prior to morphine dosing a biochemical assessment of hepatic and renal function will be obtained A 005 mgkg loading dose of morphine will be given by an intravenous infusion over 30-minutes in preterm neonates with a gestational age of less than 29 weeks followed by a continuous infusion of 0005 mgkgh whereas a loading dose of 01 mgkg will be given in preterm neonates with a gestational age of 29 weeks or more followed by a continuous infusion of 001 mgkgh Pain assessment will be performed at baseline prior to study medication administration and at 5 1 2 4 8 12 and 24 hours after the dose At each of these time points infants will be videotaped for two minutes with two cameras Videotapes will be scored afterward using standard validated pain assessment tools for preterm infants
60 preterm neonates ranging in gestational age from 22 to 32 weeks will be recruited from the NICU Stratification by gestational age will be done to ensure broad representation The decision to initiate morphine therapy will be based solely on clinical indications Prior to morphine dosing a biochemical assessment of hepatic and renal function will be obtained A 005 mgkg loading dose of morphine will be given by an intravenous infusion over 30-minutes in preterm neonates with a gestational age of less than 29 weeks followed by a continuous infusion of 0005 mgkgh whereas a loading dose of 01 mgkg will be given in preterm neonates with a gestational age of 29 weeks or more followed by a continuous infusion of 001 mgkgh Pain assessment will be performed at baseline prior to study medication administration and at 5 1 2 4 8 12 and 24 hours after the dose At each of these time points infants will be videotaped for two minutes with two cameras Videotapes will be scored afterward using standard validated pain assessment tools for preterm infants
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Inulin IND 73093 | None | None | None |