Trial · NCT07456670
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recruitment/Eligibility Proportion | Through study completion, up to 24 months | Ratio of enrolled/randomized infants to total eligible infants screened. |
| Primary | Treatment Adherence Proportion | From randomization until 24 hours after weaning from respiratory support | Percentage of per-protocol doses (caffeine/placebo) successfully administered |
| Primary | Retention Proportion | Through study completion, up to 24 months | Percentage of randomized infants who complete the study protocol until NICU discharge |
| Secondary | Time to Discharge Alive from the NICU | From the date of randomization until the date of discharge alive from NICU, assessed up to 24 months | Hours from the time of randomization to the time of discharge alive from the NICU |
| Secondary | Parent/Guardian Acceptability | Within 7 days prior to infant's NICU discharge | Frequency distribution of Likert-scale responses on the parent satisfaction survey |
| Secondary | Healthcare Provider Acceptability | Through recruitment completion, an average of 24 months | Thematic analysis of healthcare provider focus group transcripts regarding protocol viability |
| Secondary | Data Completeness | At the end of the recruitment period, approximately 24 months | Proportion of missing data points across all secondary clinical outcomes. |
| Secondary | Significant Apnea Frequency | From randomization until 24 hours after weaning from respiratory support | Mean number of apneas per day requiring intervention (stimulation, or ventilation) |
| Secondary | Total Duration of Respiratory Support | From the date of randomization until the date of discharge alive from NICU or date of death from any cause, whichever came first, assessed up to 24 months | Total hours spent on invasive and non-invasive mechanical ventilation |
| Secondary | Duration of Invasive Support | From the date of randomization until the date of discharge alive from NICU or date of death from any cause, whichever came first, assessed up to 24 months | Total hours spent specifically on invasive mechanical ventilation (intubation) |
| Secondary | Time to Full Enteral Feeding | From the date of first enteral feeding until the date when the targeted feeding volume is achieved, average of 14 days | Hours from the first feed until the infant reaches the protocol-defined "full" enteral volume |
| Secondary | Time to Full Oral Feeding | From the date of birth until the date of full oral feeding is achieved, an average of 6 weeks | Hours from birth until the infant is successfully taking all feeds by mouth (no tube) |
| Secondary | Duration of Total Parenteral Nutrition (TPN) | From the date of randomization until the date of discharge alive from NICU or date of death from any cause, whichever came first, , an average of 36 to 40 weeks post-menstrual age | Total number of days during which the infant received any volume of parenteral nutrition |
| Secondary | PMA at Weaning | At the time of weaning from respiratory support, an average of 4 to 6 weeks after birth | Mean post-menstrual age of the infant when respiratory support is successfully discontinued |
| Secondary | PMA at Discharge | At the time of NICU discharge, an average of 36 to 40 weeks post-menstrual age | Mean post-menstrual age of the infant at the time of discharge alive from the NICU. |
| Secondary | Rate of New Invasive Ventilation | From the date of randomization until the date of discharge alive from NICU or date of death from any cause, whichever came first, assessed up to 24 months | Proportion of infants not intubated at enrollment who require intubation during the study. |
| Secondary | In-hospital Mortality | From the date of randomization until the date of discharge alive from NICU or date of death from any cause, whichever came first, assessed up to 24 months | Proportion of enrolled infants who die during their initial NICU stay. |
| Secondary | Test of Infant Motor Performance (TIMP) Score | At the time of NICU discharge, an average of 36 to 40 weeks post-menstrual age | Mean score on the Test of Infant Motor Performance (TIMP). Scores range from 0 to 142, with higher scores indicating better motor maturity and performance |
| Secondary | Bronchopulmonary dysplasia (BPD) | From the date of randomization until the date of discharge alive from NICU or date of death from any cause, whichever came first, , an average of 36 to 40 weeks post-menstrual age | Proportion of enrolled infants with BPD defined as: For infants born prior to 32 weeks of gestation, this will be defined as oxygen treatment for at least 28 days with oxygen need at 36 weeks' postmenstrual age or at discharge from the NICU, whichever occurs earlier. For infants born at 32 weeks or later, this will be defined as oxygen treatment at 56 days of life or at discharge from the NICU, whichever occurs earlier. |
| Secondary | Pulmonary Hemorrhage | From the date of randomization until the date of discharge alive from NICU or date of death from any cause, whichever came first, , an average of 36 to 40 weeks post-menstrual age | Proportion of enrolled infants with pulmonary hemorrhage defined as the presence of sanguineous fluid in the trachea associated with clinical respiratory deterioration and new radiographic opacities. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07456670/registered