PrematureNCT07113535
Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants
A study testing RAM cannula and Short binasal prong in people with Premature and Respiratory Distress Syndrome, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
Trial summary
Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Read more about this study
- Who is it for?
- Ages 24 hours to 28 days
- Conditions the study is for
- Premature, Respiratory Distress Syndrome, Extubation
- What is being tested?
- RAM cannula and Short binasal prong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn preterm neonates ≤ 32 weeks of gestational and/or birth weight ≤1500 g with respiratory distress syndrome requiring initial invasive ventilation support for at least 24 hours.
Who cannot join
- Outborn preterm neonates
- Major congenital malformations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nehad Nasef, Dr contact
About this study
Official title: RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial
Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs.
The investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation.
The investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.
Read the detailed description
Preterm infants will be randomized to receive post-extubation non invasive respiratory support either through RAM cannula or SBPs. Neonates in both groups will be uniformly managed as per unit protocol as following:
Extubation criteria :
- Birth weight < 1000 gram :MAP <7 cmH2O and FIO2 <0.30
- Birth weight>1000 gram :MAP >8 cmH2O and FIO2 <0.30
Re intubation criteria :
- FIO2>0.60 to maintain SaO2 >88% OR PaO2 > 45 mmHg
- PaCO2 {arterial} > 55-60 with PH < 7.25
- Apnea and requiring bag and mask ventilation
- Evidence of increased work of breathing {retractions -grunting -chest wall distortion } plus abnormal chest x ray
- Conditions
- Premature, Respiratory Distress Syndrome, Extubation
- Being tested
- RAM cannula, Short binasal prong
- Keywords
- nasal interface, noninvasive respiratory support, premature, RAM cannula, Chest ultrasound, Diaphragm
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAM cannulaOther
RAM cannula as an interface for non invasive ventilation in preterm newborns
Short binasal prongOther
Short binasal prong as an interface for non invasive ventilation in preterm newborns
| Study group | Role | What they receive |
|---|---|---|
| RAM cannula group | Active comparator | Preterm infants will receive non-invasive ventilation by RAM cannula Receives: Other: RAM cannula |
| Short binasal prong group | Active comparator | Preterm infants will receive non-invasive ventilation by short binasal prongs Receives: Other: Short binasal prong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of extubation incidence rate
Need for reintubation within 72 hours post-extubation trial
Measured: 28 days of an infant's life
Secondary outcomes (6)
Duration of non-invasive ventilation
Days on non-invasive ventilation
Measured: 120 days
whole duration of oxygen therapy
Days on oxygen therapy during NICU admission
Measured: 120 days
Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly)
Diaphragmatic indices (diaphragmatic thickness \&excursion) and lung ultrasound scores post-extubation
Measured: 120 days
Need for reintubation within 7 days
Need for reintubation within 72 hours post-extubation trial
Measured: 28 days of an infant's life
Bronchopulmonary dysplasia
Measured: 120 days
Mortality
Pre-discharge mortality
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startAug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, hussam murayh mohammed ali, Ministry of Health, Saudi Arabia
- Investigators
- Nehad Nasef, Dr, Principal investigator, King Salman Bin Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113535
- Sponsor's protocol ID
- H-03-M-11
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Publications
Gokce IK, Kaya H, Ozdemir R. A randomized trial comparing the short binasal prong to the RAM cannula for noninvasive ventilation support of preterm infants with respiratory distress syndrome. J Matern Fetal Neonatal Med. 2021 Jun;34(12):1868-1874. doi: 10.1080/14767058.2019.1651268. Epub 2019 Aug 8.
PubMed 31394948
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07113535
- Acronym / sponsor ID
- H-03-M-11
- Conditions
- Premature, Respiratory Distress Syndrome, Extubation
- Keywords
- nasal interface, noninvasive respiratory support, premature, RAM cannula, Chest ultrasound, Diaphragm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs.
The investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation.
The investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.
Detailed description
Preterm infants will be randomized to receive post-extubation non invasive respiratory support either through RAM cannula or SBPs. Neonates in both groups will be uniformly managed as per unit protocol as following:
Extubation criteria :
- Birth weight < 1000 gram :MAP <7 cmH2O and FIO2 <0.30
- Birth weight>1000 gram :MAP >8 cmH2O and FIO2 <0.30
Re intubation criteria :
- FIO2>0.60 to maintain SaO2 >88% OR PaO2 > 45 mmHg
- PaCO2 {arterial} > 55-60 with PH < 7.25
- Apnea and requiring bag and mask ventilation
- Evidence of increased work of breathing {retractions -grunting -chest wall distortion } plus abnormal chest x ray
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAM cannula group | Active comparator | Other: RAM cannulaPreterm infants will receive non-invasive ventilation by RAM cannula |
| Short binasal prong group | Active comparator | Other: Short binasal prongPreterm infants will receive non-invasive ventilation by short binasal prongs |
Who may qualify
- Ages
- 24 hours to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inborn preterm neonates ≤ 32 weeks of gestational and/or birth weight ≤1500 g with respiratory distress syndrome requiring initial invasive ventilation support for at least 24 hours.
Key exclusion criteria (2 listed)
- Outborn preterm neonates
- Major congenital malformations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAM cannulaRAM cannula as an interface for non invasive ventilation in preterm newborns | Other | RAM cannula group |
| Short binasal prongShort binasal prong as an interface for non invasive ventilation in preterm newborns | Other | Short binasal prong group |
Primary outcome
Failure of extubation incidence rate
Time frame: 28 days of an infant's life
Need for reintubation within 72 hours post-extubation trial
6 secondary outcomes
Duration of non-invasive ventilation
Time frame: 120 days
whole duration of oxygen therapy
Time frame: 120 days
Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly)
Time frame: 120 days
Need for reintubation within 7 days
Time frame: 28 days of an infant's life
Bronchopulmonary dysplasia
Time frame: 120 days
Mortality
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 31394948Gokce IK, Kaya H, Ozdemir R. A randomized trial comparing the short binasal prong to the RAM cannula for noninvasive ventilation support of preterm infants with respiratory distress syndrome. J Matern Fetal Neonatal Med. 2021 Jun;34(12):1868-1874. doi: 10.1080/14767058.2019.1651268. Epub 2019 Aug 8.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nehad Nasef, Dr contact
Nehad Nasef, Dr principal investigator
King Salman Bin Abdulaziz Medical City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAM cannula and Short binasal prong in people with Premature and Respiratory Distress Syndrome, run by Ministry of Health, Saudi Arabia at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ohoud Almoualled, Dr (+966500550679, o.doc2or@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of extubation incidence rate (time frame: 28 days of an infant's life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07113535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.