Comparison of patient-device interface types in breathing support of newly born infants
| ISRCTN | ISRCTN10561691 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10561691 |
| Secondary identifying numbers | 10/2021/10919 |
- Submission date
- 28/05/2021
- Registration date
- 01/06/2021
- Last edited
- 09/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Continuous positive airway pressure (CPAP) is the most commonly used device for supporting the breathing of babies. However, providing effective CPAP in preterm infants have been challenging, often related to problems associated with the nasal interface. Most neonatal intensive care units (NICUs) use short nasal prongs to deliver supplemental oxygen and CPAP in neonates. These prongs are effective and safe but have the potential to cause nasal septal pressure injury and pressure leak around the nares. The RAM cannula (a canula that connects the device to the baby nose) was approved by the Food and Drug Administration for providing supplemental oxygen. It was soon adopted by clinicians to provide CPAP, largely because of its perceived ease of use and less nasal (septal) injury. Compared with the standard nasal interface for CPAP, the RAM cannula is made of softer material with a thin prong wall resulting in a larger caliber and less nasal trauma. However, there is increasing concern that the RAM cannula might be less effective in supporting the breathing of babies.
This study will compare how effective and safe these two devices are.
Who can participate
This study will include babies born at our center
What does the study involve?
Participants will be randomly allocated to receive RAM canula or nasal prongs. Participants will be closely monitored until the end of their hospital stay.
What are the possible risks and benefits?
Since both devices are used in our unit , there is no extra risks involved , however if our trial showed that one of these device is better, we will use only that device for our babies.
Where is the study run from?
Jordan University Hospital (Jordan)
When is the study starting and how long is expected to run for?
Who is funding the study?
Investigator initiated and funded
Who are the main contact?
Prof. Manar Al-lawama, manar-76@hotmail.com
Contact information
Scientific
Ahmad Ahajjaj street
Amman
11937
Jordan
 ORCID ID |
0000-0001-9313-112X |
|---|---|
| Phone | +962 799068565 |
| m.allawama@ju.edu.jo |
Study information
| Study design | Single center interventional randomized conrolled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | RAM canula versus short nasal prongs for management of respiratory distress in neonatal patients: a randomized trial |
| Study acronym | ProRAM Study |
| Study objectives | The use of RAM canula as an interface in neonates with respiratory distress is as effective as nasal prongs in providing nasal CPAP, easier for the nursing care, and causes less physical injury for the nose of the newborn infant |
| Ethics approval(s) | Approved 18/05/2021, Ethical Committee at The University of Jordan Hospital (Jordan University Hospital, Queen Rania street, PO. Box: 11943, Amman-Jordan; +962 65353666; juhwebsite@ju.edu.jo), ref: 10/2021/10919 |
| Health condition(s) or problem(s) studied | Manegment of neonates with respiratory dsitress |
| Intervention | The included neonates will be classified into 2 groups, less than 32 weeks GA, and equal to 32 or more GA. Within each group, the babies will be randomly allocated to be put on RAM canula or nasal prongs. The demographic data of the included neonates will be collected. Clinical data will include: presentation, final diagnosis, and respiratory management needed. Chest x-ray findings, blood gas results. Complications, other neonatal morbidities including intraventricular hemorrhage length of stay, and mortality. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | RAM canula, short nasal prongs |
| Primary outcome measure | Measured using data from the patients' charts and laboratory database at discharge: 1. Duration on CPAP 2. Need for escalation of respiratory support 3. Surfactant administration 4. Mortality before discharge |
| Secondary outcome measures | Measured using data from the patients' charts and laboratory database at discharge: 1. Nasal injury during respiratory support 2. Pneumothorax during respiratory support 3. Length of hospital stay 4. Chronic Lung disease at 36 weeks Post conceptional age |
| Overall study start date | 11/01/2021 |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | Neonates who have respiratory dsitress at birth |
| Key exclusion criteria | 1. Noenataes who present with respiratory distress after being transferred out of the delivery room 2. Outborns 3. Neonates diagnosed prenatally to have lung malformation 4. Neonates who are diagnosed prenatally or found at birth to have major congenital anomalies |
| Date of first enrolment | 06/06/2021 |
| Date of final enrolment | 30/08/2021 |
Locations
Countries of recruitment
- Jordan
Study participating centre
Amman
11943
Jordan
Sponsor information
University/education
Queen Rania Street
Amman
11942
Jordan
| Phone | +962 6 5355000 |
|---|---|
| Admin@ju.edu.jo | |
| Website | http://ju.edu.jo/home.aspx |
"ROR" |
https://ror.org/05k89ew48 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 10/01/2024 | 09/02/2024 | Yes | No |
Editorial Notes
09/02/2024: Publication reference added.
01/06/2021: Trial's existence confirmed by Jordan University Hospital.
