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very slow enrollment. Only one patient enrolled. Termination by PI
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The purpose of the present study is to determine whether treatment of hemodynamically significant patent ductus arteriosus with a combined therapy of intravenous Ibuprofen and oral acetaminophen has higher success rate in closing the ductus arteriosus than a standard treatment strategy of using intravenous ibuprofen alone among preterm infants.
The primary objectives of the study are to confirm the safety of oral acetaminophen in extremely low birth infants, given concomitantly with intravenous ibuprofen and also to determine its efficacy in significantly increasing the rates of ductal closure when compared to only intravenous ibuprofen therapy. Hence primary outcome variable include patent ductus arteriosus closure success rate, based on the 2-D transthoracic echocardiographic evidence.
This study is a single center, randomized, double blinded, placebo controlled trial. Preterm infants with gestational age of with a gestational age ≤27 6/7 weeks by the best obstetric estimate are eligible for enrollment.
For randomization, the study population will be stratified to two subgroups based on gestational age (GA ≤24 weeks and > 25 weeks). Randomization will occur by using computer generated random sequence, using a 4-block design, with 1:1 parallel allocation. Allocations include treatment and control arm. Treatment arm will receive combination of intravenous ibuprofen and oral acetaminophen, while control arm will receive intravenous Ibuprofen and oral placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ibuprofen and acetaminophen arm (intervention arm) | Experimental | ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses). |
|
| ibuprofen and placebo arm (control arm) | Active Comparator | ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen and acetaminophen | Drug | Intravenous ibuprofen given concomitantly with oral acetaminophen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Ductus Arteriosus Closure/Constriction | Ductal closure/constriction rate as defined based on the echocardiographic findings. Ductal closure/constriction will be defined as the complete closure of ductus or ductal diameter <1 mm | 24-48 hours after the completion of study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic Patent Ductus Arteriosus Parameters Before and After the Study Intervention | Echocardiographic parameters including ductal size (PDA size in mm), Left atrium to aortic root ratio, ductal velocity, descending aortic diastolic flow, before and after the intervention. Between the group and within the group comparison | 24-48 hours after the completion of study intervention |
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Inclusion Criteria:
Preterm infant ≤27 6/7
Written parental consent is obtained
Infant requires respiratory support
diagnosis of a persistent patent ductus arteriosus after 5 days of age, (defined as at least two of the following:
Attending neonatologist made decision to treat patent ductus arteriosus
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabien Eyal, MD | University of South Alabama | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36607 | United States |
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Overall screening for the study enrollment started 12/15/2018. Screening was continued until 10/30/2020. The study was conducted at the Neonatal Intensive Care Unit
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen and Acetaminophen Arm (Intervention Arm) | ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses). Ibuprofen and acetaminophen: Intravenous ibuprofen given concomitantly with oral acetaminophen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2018 |
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| Ibuprofen and placebo | Drug | Intravenous ibuprofen given concomitantly with oral placebo |
|
| Ventilatory Settings Before and After the Study Intervention | Ventilator parameters including Fio2, Mean airway pressure, Peak Inspiratory pressure, PEEP, and ventilatory rate oxygenation indices including Oxygenation index and Respiratory Severity score before and after intervention | 24-48 hours after the completion of study intervention |
| Proportion of Participants With Liver Injury | liver enzymes compared before and after the study intervention; if any significant elevation of liver enzymes from baseline, the participant classified as having liver injury | 24-48 hours after the completion of study intervention |
| Proportion of Participants With Renal Injury | Blood urea nitrogen (BUN) and serum creatinine before and after the study intervention are compared. Participants exhibiting significant elevation BUN and S creatine, are classified as having renal injury | 24-48 hours after the completion of study intervention |
| Proportion of Participants With Hematological Adverse Events | Hematocrit and platelet counts compared before and after the study intervention; if any significant alteration from baseline, the participant classified as having hematological adverse event, | 24-48 hours after the completion of study intervention |
| Total Number of Days of Mechanical Ventilation | The total number of days on mechanical ventilation are counted as total duration of conventional mechanical ventilation plus high frequency ventilatory days | from randomization until discharge/40 weeks post menstrual age |
| Total Number of Days of Need for Supplemental Oxygen | Cumulative days on any supplemental O2 (including Mechanical ventilation., noninvasive ventilation, nasal cannula support) calculated from randomization until 4 weeks of postmenstrual age | from randomization until discharge/40 weeks post menstrual age |
| Duration of Noninvasive Ventilation | Total cumulative days on noninvasive ventilation, including NIPPV and nasal CPAP, | from randomization until discharge/40 weeks post menstrual age |
| Proportion of Participants With Persistence of Ductus-needing Pharmacological Treatment | Proportion of participants in each group requiring open label treatment with pharmacological agents for ductal closure, e.g. IV Ibuprofen or IV Acetaminophen or IV indomethacin therapies, as decided by the treating physician | from randomization until discharge/40 weeks post menstrual age |
| Proportion of Participants Requiring Surgical Ligation of PDA | Proportion of participants in each group requiring surgical ligation of persistent PDA for definitive surgical closure | from randomization until discharge/40 weeks post menstrual age |
| Proportion of Participants Developing Bronchopulmonary Dysplasia | Proportion of participants diagnosed to have BPD based supplemental O2 requirement at 36 weeks' postmenstrual age | at 36 weeks post menstrual age |
| Percentage of Infants Requiring Home Oxygen Therapy | Proportion of participants in each group requiring home-based supplemental O2 therapy following the initial discharge from hospital. | at discharge/40 weeks post menstrual age |
| Proportion of Participants Developing Death Before Discharge | Proportion of participants in each group developing in-hospital death prior to 40 weeks of postmenstrual age. | until discharge/40 weeks post menstrual age |
| Time to Achieve Full Enteral Feeding | Duration days during the postnatal period required to achieve an enteral feeding volume of 120 ml/kg/day. | from birth until discharge/40 weeks post menstrual age |
| Total Days on Total Parenteral Nutrition | Cumulative days of receiving total parental nutrition from birth until the participant is discharged or reached postmenstrual age of 40 weeks | from birth until discharge/40 weeks post menstrual age |
| Proportion of Participants With Retinopathy of Prematurity | Proportion of participants in each group diagnosed to have retinopathy of prematurity | from birth until discharge/40 weeks post menstrual age |
| Proportion of Participants Developing Spontaneous Intestinal Perforation | Proportion of participants developing or having the diagnosis of spontaneous intestinal perforation from randomization until discharge or 40 weeks' Postmenstrual age | from randomization until discharge/40 weeks post menstrual age |
| Proportion of Participants Developing Necrotizing Enterocolitis | Proportion of participants in each group with the diagnosis of medical or surgical Necrotizing Enterocolitis | from randomization until discharge/40 weeks post menstrual age |
| Proportion of Participants Developing Gastrointestinal Hemorrhage | Proportion of participants in each group developing gastrointestinal hemorrhage following randomization until discharge or postmenstrual age of 40 weeks | from randomization until discharge/40 weeks post menstrual age |
| Proportion of Participants Developing Late Onset Sepsis | Proportion of participants diagnosed to have either probable sepsis with minimum of 7 days of antibiotic therapy or culture proven sepsis | from randomization until discharge/40 weeks post menstrual age |
| Length of Hospital Stay | Total duration (in days ) of hospital stay | from birth until discharge/40 weeks post menstrual age |
| Proportion of Participants With Periventricular Leukomalacia | Proportion of participants in each group with the evidence of periventricular leukomalacia on neurosonography | from randomization until discharge/40 weeks post menstrual age |
| FG001 | Ibuprofen and Placebo Arm (Control Arm) | ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
| COMPLETED |
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| NOT COMPLETED |
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|
Overall only one infant was enrolled into the study. Hence, control arm had no patient enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen and Acetaminophen Arm (Intervention Arm) | ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses). Ibuprofen and acetaminophen: Intravenous ibuprofen given concomitantly with oral acetaminophen |
| BG001 | Ibuprofen and Placebo Arm (Control Arm) | ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| PDA size | Number | mm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Ductus Arteriosus Closure/Constriction | Ductal closure/constriction rate as defined based on the echocardiographic findings. Ductal closure/constriction will be defined as the complete closure of ductus or ductal diameter <1 mm | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm). The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | 24-48 hours after the completion of study intervention |
|
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| Secondary | Echocardiographic Patent Ductus Arteriosus Parameters Before and After the Study Intervention | Echocardiographic parameters including ductal size (PDA size in mm), Left atrium to aortic root ratio, ductal velocity, descending aortic diastolic flow, before and after the intervention. Between the group and within the group comparison | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a continuous variable with an intended between-group and within the group comparisons. The planned analysis is not possible due to the enrollment of only one infant. Hence, no comparative or inferential statistical analysis was performed | Posted | 24-48 hours after the completion of study intervention |
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| Secondary | Ventilatory Settings Before and After the Study Intervention | Ventilator parameters including Fio2, Mean airway pressure, Peak Inspiratory pressure, PEEP, and ventilatory rate oxygenation indices including Oxygenation index and Respiratory Severity score before and after intervention | None were enrolled for the control arm. The study was terminated (very slow enrollment. Only one patient enrolled. Termination by PI). Only one infant in the intervention arm and the the specified outcome measure is a continuous variable with intended between group and within group comparison, the planned analysis is not possible due only one infant enrollment. Hence, no comparative or inferential statistical analysis was performed. | Posted | 24-48 hours after the completion of study intervention |
| |||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Liver Injury | liver enzymes compared before and after the study intervention; if any significant elevation of liver enzymes from baseline, the participant classified as having liver injury | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | 24-48 hours after the completion of study intervention |
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| Secondary | Proportion of Participants With Renal Injury | Blood urea nitrogen (BUN) and serum creatinine before and after the study intervention are compared. Participants exhibiting significant elevation BUN and S creatine, are classified as having renal injury | Overall, only one infant was enrolled into the study. One in the intervention arm and none in the control arm. The study was terminated (very slow enrollment. Only one patient enrolled. Termination by PI) The specific outcome measure is a categorical variable. As only one infant was enrolled, the data is provided as count. Any comparison between group and inferential statistics is not possible as only one infant was enrolled | Posted | Count of Participants | Participants | 24-48 hours after the completion of study intervention |
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| Secondary | Proportion of Participants With Hematological Adverse Events | Hematocrit and platelet counts compared before and after the study intervention; if any significant alteration from baseline, the participant classified as having hematological adverse event, | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | 24-48 hours after the completion of study intervention |
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| Secondary | Total Number of Days of Mechanical Ventilation | The total number of days on mechanical ventilation are counted as total duration of conventional mechanical ventilation plus high frequency ventilatory days | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a continuous variable with an intended between-group comparison. The planned analysis is not possible due to the enrollment of only one infant. Hence, no comparative or inferential statistical analysis was performed | Posted | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Total Number of Days of Need for Supplemental Oxygen | Cumulative days on any supplemental O2 (including Mechanical ventilation., noninvasive ventilation, nasal cannula support) calculated from randomization until 4 weeks of postmenstrual age | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a continuous variable with an intended between-group comparison. The planned analysis is not possible due to the enrollment of only one infant. Hence, no comparative or inferential statistical analysis was performed | Posted | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Duration of Noninvasive Ventilation | Total cumulative days on noninvasive ventilation, including NIPPV and nasal CPAP, | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm). The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a continuous variable with an intended between-group comparison. The planned analysis is not possible due to the enrollment of only one infant. Hence, no comparative or inferential statistical analysis was performed. | Posted | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants With Persistence of Ductus-needing Pharmacological Treatment | Proportion of participants in each group requiring open label treatment with pharmacological agents for ductal closure, e.g. IV Ibuprofen or IV Acetaminophen or IV indomethacin therapies, as decided by the treating physician | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible | Posted | Count of Participants | Participants | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants Requiring Surgical Ligation of PDA | Proportion of participants in each group requiring surgical ligation of persistent PDA for definitive surgical closure | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible | Posted | Count of Participants | Participants | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants Developing Bronchopulmonary Dysplasia | Proportion of participants diagnosed to have BPD based supplemental O2 requirement at 36 weeks' postmenstrual age | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm). The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible | Posted | Count of Participants | Participants | at 36 weeks post menstrual age |
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| Secondary | Percentage of Infants Requiring Home Oxygen Therapy | Proportion of participants in each group requiring home-based supplemental O2 therapy following the initial discharge from hospital. | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and the infant developed in-hospital mortality prior to the initial discharge. Hence, this outcome is not applicable. Additionally, as no one enrolled in the control arm, no inferential statistics are possible. | Posted | at discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants Developing Death Before Discharge | Proportion of participants in each group developing in-hospital death prior to 40 weeks of postmenstrual age. | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | until discharge/40 weeks post menstrual age |
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| Secondary | Time to Achieve Full Enteral Feeding | Duration days during the postnatal period required to achieve an enteral feeding volume of 120 ml/kg/day. | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a continuous variable with an intended between-group comparison. The planned analysis is not possible due to the enrollment of only one infant. Hence, no comparative or inferential statistical analysis was performed. | Posted | from birth until discharge/40 weeks post menstrual age |
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| Secondary | Total Days on Total Parenteral Nutrition | Cumulative days of receiving total parental nutrition from birth until the participant is discharged or reached postmenstrual age of 40 weeks | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a continuous variable with an intended between-group comparison. The planned analysis is not possible due to the enrollment of only one infant. Hence, no comparative or inferential statistical analysis was performed. | Posted | from birth until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants With Retinopathy of Prematurity | Proportion of participants in each group diagnosed to have retinopathy of prematurity | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | from birth until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants Developing Spontaneous Intestinal Perforation | Proportion of participants developing or having the diagnosis of spontaneous intestinal perforation from randomization until discharge or 40 weeks' Postmenstrual age | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants Developing Necrotizing Enterocolitis | Proportion of participants in each group with the diagnosis of medical or surgical Necrotizing Enterocolitis | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants Developing Gastrointestinal Hemorrhage | Proportion of participants in each group developing gastrointestinal hemorrhage following randomization until discharge or postmenstrual age of 40 weeks | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Proportion of Participants Developing Late Onset Sepsis | Proportion of participants diagnosed to have either probable sepsis with minimum of 7 days of antibiotic therapy or culture proven sepsis | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | from randomization until discharge/40 weeks post menstrual age |
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| Secondary | Length of Hospital Stay | Total duration (in days ) of hospital stay | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a continuous variable with an intended between-group comparison. The planned analysis is not possible due to the enrollment of only one infant. Hence, no comparative or inferential statistical analysis was performed. | Posted | from birth until discharge/40 weeks post menstrual age |
| |||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Periventricular Leukomalacia | Proportion of participants in each group with the evidence of periventricular leukomalacia on neurosonography | Overall, only one participant was enrolled into the study (one in the intervention arm and none in the control arm. The study was terminated (very slow enrolment, termination by PI). The specified outcome measure is a categorical variable, and as only one infant was enrolled, the outcome has been reported as a count. As no one enrolled in the control arm, no inferential statistics are possible. | Posted | Count of Participants | Participants | from randomization until discharge/40 weeks post menstrual age |
|
4 months
None were enrolled into control arm, Therefore, number infants at risk for adverse events under the control arm are zero
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen and Acetaminophen Arm (Intervention Arm) | ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses). Ibuprofen and acetaminophen: Intravenous ibuprofen given concomitantly with oral acetaminophen | 1 | 1 | 0 | 1 | 1 | 1 |
| EG001 | Ibuprofen and Placebo Arm (Control Arm) | ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biochemical evidence of acute kidney injury with preserved renal function, probably nor related to i | Renal and urinary disorders | Systematic Assessment | As per the study protocol, after the completion of study intervention, kidney function was monitored using BUN and serum creatinine. S. creatinine was noted to be 2 times above the baseline pre-intervention level (1.28 mg/dl). Renal function normal |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramachandra Bhat | University of South Alabama | 2514151055 | rambhat79@gmail.com |
| Apr 18, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D047928 | Premature Birth |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.
Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo
|
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
|
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
|
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.
Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.
Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo
|
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
|
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.
Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo
|
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|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals. Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo |
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ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.
Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo
|
|
ibuprofen and placebo will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.
Ibuprofen and placebo: Intravenous ibuprofen given concomitantly with oral placebo
|
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