| Primary | Number of Days Between Randomization and Hospital Discharge | The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death. | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | days | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
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| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00018(10 to 30)
- OG00116.5(10 to 27)
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| Secondary | The Number of Days to Physiologic Maturity After Randomization | The number of days to physiologic maturity after randomization. Physiologic maturity is defined: 1. Temperature: out of the incubator for at least 48 hours with normal body temperature; 2. Feeding: oral feeding at a volume of at least 140 ml/kg for 48 hours or growing on less than 140 ml/kg/day for at least 48 hours; 3. Respiratory: apnea-free for at least 5 consecutive days. This outcome is censored at 48 weeks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | days | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs | The number of days to when out of incubator for 48 hours: when maintained stable temp for 48 hrs. This outcome is censored at 48 weeks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | days | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days | The number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | days | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | The Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 Hours | The number of days oral feeds >140 ml/kg/day or growing on less than 140 ml/kg/day for at least 48 hours. This outcome is censored at 48 weeks PMA | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | days | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Post-menstrual Age at Discharge | The post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Mean | 95% Confidence Interval | weeks | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Weight Gain From Randomization Until Status | Weight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%). | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Mean | 95% Confidence Interval | grams per day | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart | The number of days after randomization until status that infant had at least two consecutive heart rates >200 documented at least 3 hours apart | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | days | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Treatment for High Blood Pressure | Treatment for high blood pressure initiated after randomization until status. | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Count of Participants | | Participants | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours | The number of episodes between randomization and status that infant was placed NPO for >= 24 hours | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | episodes | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Use of Anti-reflux Medications | The use of anti-reflux medications started between randomization and status | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Count of Participants | | Participants | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of Days That Significant Apnea/Bradycardia | The number of days that significant apnea/bradycardia, as defined by documentation of infant receiving any of the following between randomization and status: open label caffeine, other methylxanthines, doxapram, CPAP or ventilatory support for apnea/bradycardia. | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | days | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | All-cause Mortality | | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Count of Participants | | Participants | | Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of All-cause Readmissions Within First 4 Weeks Post-discharge | Number of all-cause readmissions within first 4 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of readmissions | | Discharge through 4 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of All-cause Readmissions Within Second 4 Weeks Post-discharge | Number of all-cause readmissions within second 4 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of readmissions | | 4 weeks through 8 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of All-cause Readmissions Within First 8 Weeks Post-discharge | Number of all-cause readmissions within first 8 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of readmissions | | Discharge through 8 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-discharge | Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 4 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of sick visits | | Discharge through 4 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge | Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within second 4 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of sick visits | | 4 weeks through 8 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-discharge | Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 8 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of sick visits | | Discharge through 8 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Primary | Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge | Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of apnea visits | | Discharge through 4 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge | Number of sick visits related to apneic or apparent life-threatening events within second 4 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of apnea visits | | 4 weeks through 8 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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| Secondary | Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge | Number of sick visits related to apneic or apparent life-threatening events within first 8 weeks post-discharge | An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data. | Posted | | Median | Inter-Quartile Range | count of apnea visits | | Discharge through 8 weeks post-discharge | | | | ID | Title | Description |
|---|
| OG000 | Caffeine | Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians | | OG001 | Placebo | Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians |
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