Respiratory Distress Syndrome in Premature InfantNCT03620448
Immediate Treatment Outcomes of b-CPAP vs Oxygen Therapy in Preterm Babies Presenting With RDS at KCMC
A study testing bCPAP Arm and Oxygen Arm in people with Respiratory Distress Syndrome in Premature Infant, run by Kilimanjaro Christian Medical Centre, Tanzania.
Trial summary
Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress syndrome in the neighbouring countries. Read more about this study
- Who is it for?
- Ages 28 to 37 weeks
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- bCPAP Arm and Oxygen Arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2016to 15 May 2017
- Phase
- Interventional
- 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 28 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterm babies (< 37 weeks of gestation determined using Finnstorm score) presenting with signs of RDS (tachypnea of >60breaths /min, intercostal and subcostal recessions, nasal flaring, grunting and cyanosis)
Who cannot join
- Preterm babies with birthweight less than 1kg (bCPAP machine can only be used in babies with body weight of 1-10kg)
- Congenital malformations (cleft palate and lip, tracheal esophageal fistula and diaphragmatic hernia)
- Mothers who refused to consent
About this study
Official title: Immediate Treatment Outcomes of Bubble-cpap Versus Oxygen Therapy in Preterm Babies Presenting With Respiratory Distress Syndrome at Kilimanjaro Christian Medical Center
Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress syndrome in the neighbouring countries. This study aims to implement and determine the effectiveness of bCPAP and its immediate outcomes compared to oxygen therapy in preterm babies presenting with respiratory distress syndrome (RDS).
Read the detailed description
Effective treatment of preterm babies with RDS requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in developing countries.
bCPAP is generated by exhalation against a constant opening pressure that produces positive end-expiratory pressure. This in-turn helps in maintaining lung volume at the end of expiration, preventing atelectasis, improving oxygenation, reducing respiratory fatigue and eventually preventing respiratory failure. bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components: : (i)An air compressor connected to an oxygen concentrator with a gas flow fate of 3-4 L/min; (ii) A nasal interface (short nasal prongs) connecting the baby's airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the expiratory limb connected to the water bottle and; (iii) An expiratory limb with the distal end submerged 6 cm in water to generate an end expiratory pressure
At the neonatal unit at Kilimanjaro Christian Medical Center (KCMC), the standard of care for Preterm babies with RDS is receiving oxygen therapy via nasal prongs from oxygen cylinders.
- Being tested
- bCPAP Arm, Oxygen Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bCPAP ArmDevice
bCPAP (Rice 360◦c low cost bCPAP device)
Oxygen ArmOther
Oxygen therapy from oxygen cylinders
| Study group | Role | What they receive |
|---|---|---|
| bCPAP Arm. | Experimental | Babies randomized to receive bCPAP were started (by principle investigator assisted by a clinician) on bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components:
(i) An oxygen concentrator with a gas flow fate of 3-4L/min, (ii) A nasal interface (short nasal prongs) connecting the baby's airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the expiratory limb connected to the water bottle and (iii) An expiratory limb with the distal end submerged 6cm in water to generate an end expiratory pressure as seen in appendix 7. adopted from suppliers of the pumani bCPAP machine in Kenya. Receives: Device: bCPAP Arm |
| Oxygen Arm | Other | Preterms on the control arm and those whose parents didn't consent received the standard treatment for RDS i.e pure oxygen via nasal prongs from the oxygen cylinders. Receives: Other: Oxygen Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the number of babies that survived with bCPAP treatment versus Oxygen therapy
The proportion of babies discharged alive in the bCPAP arm versus the oxygen therapy arm.
Measured: 6 months
Secondary outcomes (3)
Treatment duration
The time spent on the allocated treatment arm till RDS symptoms (tachypnea (>60breaths/min), intercostal and subcostal recessions, nasal flaring, grunting and cyanosis) resolve.
Measured: 6 months
Duration of hospital stay
Time from admission into the neonatal ward to discharge (dead or alive).
Measured: 6 months
Treatment complications
Whilst the subject is receiving treatment, the following complications will be observed and recorded; like pneumothorax, nasal bleeding, injury to the skin, nose or eye, aspiration pneumonia, vomiting and any other complication considered related to the treatment as per the principal investigator's clinical judgement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Dec 2016
- Primary completion15 May 2017
- Study completion15 May 2017
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 Respiratory Distress Syndrome in Premature InfantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kilimanjaro Christian Medical Centre, Tanzania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Annette M Baine, Kilimanjaro Christian Medical Centre, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620448
- Sponsor's protocol ID
- CPAP1
- Status last verified
- Aug 2018
- First submitted
- 2 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified participant data will be shared as per the local country guidelines.
Publications
Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, Gest A, Smith EO, Oden M, Richards-Kortum RR, Molyneux E. Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi. PLoS One. 2014 Jan 29;9(1):e86327. doi: 10.1371/journal.pone.0086327. eCollection 2014.
PubMed 24489715
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Treatment Outcomes of Bubble-cpap Versus Oxygen Therapy in Preterm Babies Presenting With Respiratory Distress Syndrome at Kilimanjaro Christian Medical Center
- ClinicalTrials.gov ID
- NCT03620448
- Acronym / sponsor ID
- CPAP1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kilimanjaro Christian Medical Centre, TanzaniaUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 8 Aug 2018 (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.
Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress syndrome in the neighbouring countries. This study aims to implement and determine the effectiveness of bCPAP and its immediate outcomes compared to oxygen therapy in preterm babies presenting with respiratory distress syndrome (RDS).
Detailed description
Effective treatment of preterm babies with RDS requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in developing countries.
bCPAP is generated by exhalation against a constant opening pressure that produces positive end-expiratory pressure. This in-turn helps in maintaining lung volume at the end of expiration, preventing atelectasis, improving oxygenation, reducing respiratory fatigue and eventually preventing respiratory failure. bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components: : (i)An air compressor connected to an oxygen concentrator with a gas flow fate of 3-4 L/min; (ii) A nasal interface (short nasal prongs) connecting the baby's airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the expiratory limb connected to the water bottle and; (iii) An expiratory limb with the distal end submerged 6 cm in water to generate an end expiratory pressure
At the neonatal unit at Kilimanjaro Christian Medical Center (KCMC), the standard of care for Preterm babies with RDS is receiving oxygen therapy via nasal prongs from oxygen cylinders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bCPAP Arm. | Experimental | Device: bCPAP ArmBabies randomized to receive bCPAP were started (by principle investigator assisted by a clinician) on bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components: (i) An oxygen concentrator with a gas flow fate of 3-4L/min, (ii) A nasal interface (short nasal prongs) connecting the baby's airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the expiratory limb connected to the water bottle and (iii) An expiratory limb with the distal end submerged 6cm in water to generate an end expiratory pressure as seen in appendix 7. adopted from suppliers of the pumani bCPAP machine in Kenya. |
| Oxygen Arm | Other | Other: Oxygen ArmPreterms on the control arm and those whose parents didn't consent received the standard treatment for RDS i.e pure oxygen via nasal prongs from the oxygen cylinders. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All preterm babies (< 37 weeks of gestation determined using Finnstorm score) presenting with signs of RDS (tachypnea of >60breaths /min, intercostal and subcostal recessions, nasal flaring, grunting and cyanosis)
Key exclusion criteria (3 listed)
- Preterm babies with birthweight less than 1kg (bCPAP machine can only be used in babies with body weight of 1-10kg)
- Congenital malformations (cleft palate and lip, tracheal esophageal fistula and diaphragmatic hernia)
- Mothers who refused to consent
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 |
|---|---|---|
| bCPAP ArmbCPAP (Rice 360◦c low cost bCPAP device) | Device | bCPAP Arm. |
| Oxygen ArmOxygen therapy from oxygen cylinders | Other | Oxygen Arm |
Primary outcome
Comparing the number of babies that survived with bCPAP treatment versus Oxygen therapy
Time frame: 6 months
The proportion of babies discharged alive in the bCPAP arm versus the oxygen therapy arm.
3 secondary outcomes
Treatment duration
Time frame: 6 months
Duration of hospital stay
Time frame: 6 months
Treatment complications
Time frame: 6 months
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 8 Aug 2018.
- Results publication: PubMed 24489715Kawaza K, Machen HE, Brown J, Mwanza Z, Iniguez S, Gest A, Smith EO, Oden M, Richards-Kortum RR, Molyneux E. Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi. PLoS One. 2014 Jan 29;9(1):e86327. doi: 10.1371/journal.pone.0086327. eCollection 2014.
- Individual participant dataSharing planned: Yes. De-identified participant data will be shared as per the local country guidelines.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing bCPAP Arm and Oxygen Arm in people with Respiratory Distress Syndrome in Premature Infant, run by Kilimanjaro Christian Medical Centre, Tanzania.
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 3 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Comparing the number of babies that survived with bCPAP treatment versus Oxygen therapy (time frame: 6 months). 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 NCT03620448, 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 2018.