Trial · NCT01778634
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU). |
| Secondary | Number of Participants Who Survived Until 36 Wks Postmenstrual Age With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age | 36 weeks post menstrual age (one month prior to due date) | Number of Participants who survived until 36 wks postmenstrual age with Physiologic defined bronchopulmonary dysplasia (BPD) based on oxygen-saturation monitoring |
| Secondary | Number of Participants With Death or Neurodevelopmental Impairment | 22-26 months | Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score \<70. |
| Secondary | Number of Participants With Pulmonary Impairment | 6-26 months | Parent report of recurrent wheezing and/or chronic cough |
| Secondary | Number of Participants Who Died | 22-26 months | Number of Participants who died from any cause |
| Secondary | Duration of Positive Pressure Support | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support. |
| Secondary | Duration of Oxygen Supplementation | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Cumulative number of days of receipt of supplemental oxygen |
| Secondary | Number of Participants Who Experienced Air Leaks | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray |
| Secondary | Number of Participants Who Received Postnatal Steroids | 36 weeks | Receipt of steroid medications (hydrocortisone, dexamethasone) |
| Secondary | Number of Participants Who Received Non-Study Antibiotics | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Received Non-study antibiotics following study drug intervention period. |
| Secondary | Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations | Study day 1-day 7 | Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants. |
| Other | Number of Participants With Threshold Retinopathy of Prematurity (ROP) | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Threshold ROP requiring surgical intervention as diagnosed by ophthalmologic examination |
| Other | Number of Participants With Necrotizing Enterocolitis (NEC) | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Necrotizing enterocolitis ≥ Bell Stage II by radiographic and clinical criteria. |
| Other | Number of Participants With Infections During the NICU Hospitalization | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Culture-confirmed bacterial or fungal infection based on culture from sterile site (blood, cerebral spinal fluid, or urine) |
| Other | Number of Participants With Severe Intraventicular Hemorrhage (IVH) | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | Number of Participants with Grade III or IV IVH confirmed by cranial ultrasound |
| Other | Number of Participants With Periventricular Leukomalacia (PVL) | Participants will be followed for the duration of hospital stay, an expected average of 10 weeks | The number of Participants with cranial ultrasound confirmed PVL |
| Other | Number of Participants With Patent Ductus Arteriosus (PDA) | 14 days | Detection of PDA by cardiac echocardiogram with left to right shunting, or clinical evidence of murmur, bounding pulses, and widened pulse pressure. |
| Other | Number of Participants With Cardiac Arrhythmia | 3 days | Number of Participants with EKG evidence of prolonged QT (QTc \> 450 ms) |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01778634/registered