Phase 4
Completed N=14
Preterm Infant Inhaled Albuterol Dosing
Source: ClinicalTrials.gov NCT02447250 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Change in Respiratory Resistance — 0.011; 0.006; 0.014 cm h2o/mL/sec
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to help determine the best dose of inhaled albuterol sulfate in premature babies at risk of developing bronchopulmonary dysplasia (BPD). BPD is the chronic lung disease of prematurity and is associated with increased morbidity and mortality, longer hospital stays, and increased healthcare utilization. Albuterol is an inhaled medication frequently used in premature infants with chronic lung disease and in people with asthma. It is believed to be safe, but the optimal dose for infants is not clear. The investigators hypothesize that albuterol may help a subset of premature infants with lung disease, but they need to determine the best dose prior to doing research about how effective it is for chronic lung disease/BPD. Response to each of three doses of albuterol will be measure using pulmonary function tests.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Respiratory Resistance |
0.011; 0.006; 0.014 | — |
| SECONDARY Number of Participants With Positive Response at Different Albuterol Doses |
6; 4; 4 | — |
| SECONDARY Birth Weight of Albuterol Responders vs Non Responders |
847.2; 1147.7 | 0.14 |
| SECONDARY Gestational Age at Birth |
26.7; 28.5 | 0.16 |
| SECONDARY Etiology of Preterm Delivery |
4; 6 | 1.0 |
Eligibility Criteria
Inclusion Criteria
- very low birthweight infant (<1500g)
- gestational age at birth <32 weeks
- age 14 or more days and corrected to 28w0d to 33w6d gestational age
- continuing to require respiratory support and/or supplemental oxygen
Exclusion Criteria
- chromosomal abnormalities
- major congenital anomalies
- congenital heart disease, except atrial septal defect and patent ductus arteriosus
- clinical providers determine subject too unstable to undergo pulmonary function testing
Data sourced from ClinicalTrials.gov (NCT02447250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.