Pharmacological Action of DrugEarly Phase 1NCT06097767
the Incidence of Necrotizing Enterocolitis in Preterm With Respiratory Distress Syndrome Undergoing Caffeine Therapy
A Early Phase 1 study testing Caffeine citrate and Amikacin in people with Pharmacological Action of Drug, run by Al-Azhar University at 1 site in Egypt.
Trial summary
It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome. The purpose of this study is to : 1. Read more about this study
- Who is it for?
- Ages 32 to 35 weeks
- Conditions the study is for
- Pharmacological Action of Drug
- What is being tested?
- Caffeine citrate and Amikacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Oct 2023to 30 Jul 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 32 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterm infants with respiratory distress syndrome.
Who cannot join
- Preterm admitted to NICU for other reasons rather than respiratory distress
- Major congenital anomalies
- spontaneous intestinal perforation
- Endocrinal Dysfunctions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy
It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome.
The purpose of this study is to :
Read more
- Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
- Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care
1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks.
2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.
- Conditions
- Pharmacological Action of Drug
- Being tested
- Caffeine citrate, Amikacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine citrateDrug
It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.
AmikacinDrug
it includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS Receives: Drug: Amikacin |
| Caffeine-treated group | Active comparator | It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection. Receives: Drug: Caffeine citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
decreasing NEC rates
decreasing NEC rates and stage ≥2 and death.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start19 Oct 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological Action of DrugStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Alaa Mohamed Kamel Morsy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097767
- Sponsor's protocol ID
- RHDIRB2018122001/2116
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Incidence of Necrotizing Enterocolitis in Preterm Infants With Respiratory Distress Syndrome Undergoing Caffeine Therapy
- ClinicalTrials.gov ID
- NCT06097767
- Acronym / sponsor ID
- RHDIRB2018122001/2116
- Conditions
- Pharmacological Action of Drug
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 24 Oct 2023 (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.
It is a randomized, prospective study; it will be carried out in the NICU at Alzahraa University Hospital including 50 newborn babies diagnosed with respiratory distress syndrome.
The purpose of this study is to :
- Investigate the protective caffeine on necrotizing enterocolitis in respiratory distress syndrome preterm infants.
- Detect the impact of caffeine protocol treatment on the in-incidence of necrotizing enterocolitis in respiratory distress syndrome preterm infants in neonatal intensive care
1- Control group It includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks.
2- Caffeine-treated group It includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: AmikacinIt includes preterm infants with respiratory distress syndrome aged 32 weeks-35 weeks receives regular intervention for RDS |
| Caffeine-treated group | Active comparator | Drug: Caffeine citrateIt includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection. |
Who may qualify
- Ages
- 32 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All preterm infants with respiratory distress syndrome.
Key exclusion criteria (4 listed)
- Preterm admitted to NICU for other reasons rather than respiratory distress
- Major congenital anomalies
- spontaneous intestinal perforation
- Endocrinal Dysfunctions
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 |
|---|---|---|
| Caffeine citrateIt includes preterm infants with respiratory distress syndrome who received caffeine treatment as intravenous caffeinospire (Caffeine citrate) 60 mg / 3 ml (20 mg /ml) 3 ml vial for injection. | Drug | Caffeine-treated group |
| Amikacinit includes preterm infants with respiratory distress syndrome who received amikacin in regular intervention therapy in control group | Drug | Control group |
Primary outcome
decreasing NEC rates
Time frame: 1 year
decreasing NEC rates and stage ≥2 and death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Caffeine citrate and Amikacin in people with Pharmacological Action of Drug, run by Al-Azhar University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Oct 2023. 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decreasing NEC rates (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2023.