ApneaPhase 3NCT02103777

High Versus Low Dose of Caffeine for Apnea of Prematurity

A Phase 3 study testing Caffeine citrate in people with Apnea and Preterm Infants, run by Mansoura University Children Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The optimum caffeine dose for apnea of prematurity has not been well investigated so the objective of the study is to compare high versus low dose of caffeine citrate to facilitate successful extubation in mechanically ventilated preterm infants. Read more about this study

Who is it for?: Ages 1 day to 10 days
Conditions the study is for: Apnea, Preterm Infants
What is being tested?: Caffeine citrate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteEgypt
Study dates: Sep 2011to Sep 2013
Phase: Phase 3
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 1 day to 10 days
All sexes
No healthy volunteers
Child

Who may be able to join

newborn infant less than 32 weeks gestation with the diagnosis of apnea

Who cannot join

newborn infants with gestational age more than 32 weeks.
newborn infant with congenital malformations or chromosomal anomalies.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Mansoura University Children Hospital
Al Mansurah, El Dakahlya, 35111

Other trials in Egypt

About this study

Official title: High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial

Read the detailed description

A randomized, double blind, clinical trial which will be conducted in Neonatal Intensive Care Unit, Mansoura University Children Hospital, Egypt on preterm infants born less than 32 weeks gestation mechanically ventilated within the first 10 days of life to study the optimum caffeine dose for apnea of prematurity and compare High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) versus low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine citrate started within the first 10 days of life and its effect on need of re-intubation within 72 hours of extubation from mechanical ventilation as primary outcome and frequency and duration of apnea, duration of mechanical ventilation and oxygen support, length of hospital stay, neonatal mortality, chronic lung disease, necrotising enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, hydrocephalus, retinopathy of prematurity, and caffeine side effects as secondary outcomes.

Conditions: Apnea, Preterm Infants
Being tested: Caffeine citrate
Keywords: high dose of caffeine, low dose of caffeine, prevention
Medical subject headings: Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Caffeine citrateDrug
Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

Study groups in NCT02103777
Study group	Role	What they receive
High dose caffeine	Active comparator	High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) Receives: Drug: Caffeine citrate
Low dose caffeine	Active comparator	Low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine. Receives: Drug: Caffeine citrate

What is being measured

The primary outcome is the main question the study is designed to answer.

Successful extubation from mechanical ventilation
Need of re-intubation within 72 hours of extubation from mechanical ventilation
Measured: 72 hours after extubation from mechanical ventilation

Secondary outcomes (11)

Apnea of prematurity
Frequency and documented days of apnea
Measured: Expected average of 8 weeks post natal age
Duration of mechanical ventilation and oxygen support
Measured: Expected 4 to 6 weeks postnatal age
length of hospital stay
Measured: Expected 8 weeks
Neonatal mortality
Death before hospital discharge
Measured: Expected 8 weeks
Chronic lung disease
Need for oxygen by 36 weeks corrected gestational age
Measured: By 36 weeks corrected gestational age
Necrotising enterocolitis
Measured: Expected 6 weeks
Intraventricular haemorrhage
Measured: Expected 2 weeks
Periventricular leukomalacia
Measured: Expected 8 weeks
Hydrocephalus
Measured: Expected 8 weeks
Retinopathy of prematurity
Measured: Expected 8 weeks
Caffeine side effects.
Measured: Expected 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Sep 2013

First posted4 Apr 2014 (estimated)
Study startSep 2011
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ApneaStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02103777
Sponsor's protocol ID: NICU MUCH 2013
Status last verified: Apr 2014
First submitted: 27 Mar 2014
Last updated: 4 Apr 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
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Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
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Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
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Comprehensive Opioid Management and Breathing During Sleep
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All Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial
ClinicalTrials.gov ID: NCT02103777
Acronym / sponsor ID: NICU MUCH 2013
Conditions: Apnea, Preterm Infants
Keywords: high dose of caffeine, low dose of caffeine, prevention
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Mansoura University Children HospitalUniversity, hospital or other
Study start: Sep 2011
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 4 Apr 2014 (estimated)
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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
High dose caffeine	Active comparator	Drug: Caffeine citrateHigh dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base)
Low dose caffeine	Active comparator	Drug: Caffeine citrateLow dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine.

Who may qualify

Ages: 1 day to 10 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

newborn infant less than 32 weeks gestation with the diagnosis of apnea

Key exclusion criteria (2 listed)

newborn infants with gestational age more than 32 weeks.
newborn infant with congenital malformations or chromosomal anomalies.

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 citrateCaffeine will be given by either high dose in Arm 1 or low dose in Arm 2	Drug	High dose caffeine, Low dose caffeine

Primary outcome

Successful extubation from mechanical ventilation
Time frame: 72 hours after extubation from mechanical ventilation
Need of re-intubation within 72 hours of extubation from mechanical ventilation

11 secondary outcomes

Apnea of prematurity
Time frame: Expected average of 8 weeks post natal age
Duration of mechanical ventilation and oxygen support
Time frame: Expected 4 to 6 weeks postnatal age
length of hospital stay
Time frame: Expected 8 weeks
Neonatal mortality
Time frame: Expected 8 weeks
Chronic lung disease
Time frame: By 36 weeks corrected gestational age
Necrotising enterocolitis
Time frame: Expected 6 weeks
Intraventricular haemorrhage
Time frame: Expected 2 weeks
Periventricular leukomalacia
Time frame: Expected 8 weeks
Hydrocephalus
Time frame: Expected 8 weeks
Retinopathy of prematurity
Time frame: Expected 8 weeks
Caffeine side effects.
Time frame: Expected 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2014.

Related trials for Apnea

Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea

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.

sameh m abbas, master principal investigator

Mansoura University Children Hospital

nehad a nasef, MD study director

Mansoura University Children Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Caffeine citrate in people with Apnea and Preterm Infants, run by Mansoura University Children Hospital 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 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: finished, as of the sponsor's last update on 4 Apr 2014. 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Successful extubation from mechanical ventilation (time frame: 72 hours after extubation from mechanical ventilation). 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 NCT02103777.

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 4 Apr 2014.