A Phase 3 interventional study of Indomethacin and Acetaminophen in Patent Ductus Arteriosus, sponsored by University of Tennessee. Terminated at 3 sites in United States. Open to participants aged 22 Weeks to 32 Weeks. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by University of Tennessee · Phase 3, Interventional, and Treatment
The purpose of this study is to see if acetaminophen (Tylenol) is as effective as indomethacin in closing patent ductus arteriosus in premature infants.
The study will be a randomized, controlled, non-inferiority trial, and the investigators plan to enroll premature infants \<32 weeks, \<1500g, and who are \< 21 days of age at Regional One Health, LeBonheur Children's Hospital, and Methodist Germantown NICUs in Memphis, TN. A study group of 42 patients for each group will be needed to allow a maximum difference of 25% to consider non-inferiority in the closure rate between IV acetaminophen and IV indomethacin (with power of 80% and alpha of 0.05).2 The investigators' goal will be to enroll 50 infants for each treatment group, to help with an expected 20% drop out rate either due to complications or parents removal of consent. Dosages: IV acetaminophen 15mg/kg/dose every 6 hours for 12 doses,6 IV indomethacin dose will depend on age.IV indomethacin will be given every 12 hours for 3 doses. The infants will be eligible for the study after primary attending has made the decision to treat the hsPDA. The goal will be 50 infants in the IV acetaminophen group and 50 infants in the IV indomethacin group.
Informed consent will be obtained from the parent after ECHO has been obtained and the primary attending has decided to treat PDA in the infant who meets inclusion criteria without any of the exclusion criteria. The investigators will use block randomization and stratify by site to generate 140 random values of either 0 for acetaminophen or 1 for indomethacin. The goal will be 50 infants randomized to acetaminophen group and 50 infants randomized to indomethacin group. The numbers will be placed in opaque envelope and opened after consent is obtained. The primary team will not be blinded given the different frequencies of administration of acetaminophen and indomethacin. The first ECHO will be read by staff pediatric cardiologist. A pediatric cardiologist will retrospectively go back and read all ECHOs blinded for standardization.
Prior to induction of treatment, we will record complete blood count (CBC) and complete metabolic panel (CMP) with AST/ALT. After treatment, the investigators will record AST/ALT within 48 hours, and will record follow-up ECHO reports that occur within seven days of initiation of treatment. The decision to repeat treatment will be left to primary attending's discretion. The primary attending will determine any additional medical or surgical treatment if indicated. Data regarding ROP, IVH, and BPD will be collected from patient's chart prior to discharge.
Primary outcome will be the rate of successful PDA treatment by ECHO in each group. Successful PDA treatment will be defined as no longer meeting ECHO criteria for hsPDA. Secondary outcome data will be recorded and include the following: retreatment, surgical closure, days on invasive mechanical ventilation, duration of supplemental oxygen requirement, respiratory support at 36 weeks post-menstrual age (PMA), NEC, ROP, days to full feeds, gastrointestinal perforation, length of stay, renal dysfunction defined by UOP \< 1cc/kg/hr in an 8 hour period, creatinine elevation greater than 1.5 mg/dL, and discharge disposition.
144 studies on the registry are indexed under Ductus Arteriosus, Patent; 17 are open to participants now.
This study's enrollment of 37 is below the median of 80 across 81 interventional studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →University of Tennessee is the lead sponsor of 139 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Left-to-right ductal flow AND 2 of the following 3:
Exclusion Criteria:
Indomethacin as drug to treat PDA.
Drug: Indomethacin
Acetaminophen as drug to treat PDA.
Drug: Acetaminophen
IV indomethacin will be given every 12 hours for 3 doses. If \<48 hours old, 1st dose 0.2 mg/kg, 2nd dose 0.1 mg/kg, and 3rd dose 0.1mg/kg. If 2-7 days old, 1st dose 0.2 mg/kg, 2nd dose 0.2 mg/kg, and 3rd dose 0.2 mg/kg. If \>7 days old, 1st dose 0.2 mg/kg, 2nd dose 0.25 mg/kg, and 3rd dose 0.25 mg/kg.
Also known as: Indocin
15mg/kg/dose every 6 hours for 12 doses
Also known as: Ofirmev
Successful treatment of PDA closure
Definition of successful treatment of PDA is the PDA no longer meets the echocardiogram inclusion criteria.
Time frame: Follow-up ECHO to assess for closure within 7 days of treatment initiation
PDA retreatment
Did the patient require a second course of treatment with either indomethacin or acetaminophen. Did the PDA require surgical closure.
Time frame: 1 year
Supplement O2 requirement at 36 weeks PMA
Was infant on \>21% O2 at 36 weeks post-menstrual age
Time frame: Until 36 weeks PMA
Nectrotizing enterocolitis
As defined by Bell's Staging criteria, at any time during hospital stay
Time frame: 1 year
Gastrointestinal perforation
As defined by xray demonstration of free peritoneal air or as diagnosed by surgery
Time frame: 1 year
Mortality
Death before discharge from NICU stay
Time frame: 1 year
Days on invasive mechanical ventilation
Days on invasive mechanical ventilation
Time frame: 1 year
Days on supplement oxygen
Days on supplement oxygen
Time frame: 1 year
Days to full feeds
Day till the infant reaches 120 kcal/kg/d
Time frame: 1 year
Length of stay
Time from NICU admission to NICU discharge
Time frame: 1 year
Retinopathy of prematurity
Stage of ROP and if any treatment was needed
Time frame: 1 year
Creatinine elevation greater than 1.5 mg/dL
Creatinine elevation greater than 1.5 mg/dL
Time frame: 1 year
Plan to share: No
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Tennessee