Birth AsphyxiaHBB-PromptNCT03577054
Development of a Mobile Application for HBB Prompt Study
A study testing HBB Prompt and Low-Dose High Frequency training in people with Birth Asphyxia and Neonatal Death, run by Mbarara University of Science and Technology at 1 site in Uganda.
Trial summary
This study applies an iterative user-centred design approach involving frontline birth attendants to create a mobile application ("HBB Prompt") to improve skills retention after initial newborn stabilization training through the Helping Babies Breathe (HBB) program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Birth Asphyxia, Neonatal Death
- What is being tested?
- HBB Prompt and Low-Dose High Frequency training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUganda
- Study dates
- 14 May 2018to 30 Jun 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Frontline birth attendants involved in the delivery or care of babies in the maternity ward, theater or pediatric wards with a possibility of involvement in newborn resuscitation.
Who cannot join
- Health workers providing care in other wards other than maternity and pediatrics.
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mbarara University of Science and Technology
Mbarara
Santorino Data, MBChB, MMed, 256712214458, sdata@must.ac.ug
Santorino Data, MBChB, MMed
About this study
Official title: Development of a Mobile Application Through User Centered Design to Improve Helping Babies Breath Skills Retention
This study applies an iterative user-centred design approach involving frontline birth attendants to create a mobile application ("HBB Prompt") to improve skills retention after initial newborn stabilization training through the Helping Babies Breathe (HBB) program. HBB Prompt will then be piloted at one site after HBB training and skills retention will be compared with a control site without HBB Prompt after HBB training.
Read the detailed description
Helping Babies Breathe (HBB) is a newborn stabilization course that has been shown to reduce neonatal mortality by up to 47%. Such mortality impact is however not sustained due to rapid skills deterioration.
The investigators propose to improve sustainability of HBB's impact by increasing skills retention with an innovative mobile application called HBB Prompt. HBB Prompt will be an interactive tool that guides frontline providers through the steps needed to save newborn babies at birth. HBB Prompt will facilitate individual and group training in health facilities using the Low Dose High Frequency model (LDHF) for resuscitation skills retention.
The investigators will robustly develop HBB Prompt by integrating human factors and user-centered design approaches. The investigators will engage end-users and HBB Master Trainers to iteratively collect feedback to develop HBB Prompt for both individual and small group resuscitation practice. The iterative approach will mitigate the common scenario of mobile health (mHealth) solutions unable to achieve sustained success at scale due to lack of comprehensive input from frontline users.
The investigators will pilot the app at a single centre and compare it to a control site for HBB skills retention at different time points after initial HBB training.
- Conditions
- Birth Asphyxia, Neonatal Death
- Being tested
- HBB Prompt, Low-Dose High Frequency training
- Keywords
- Helping Babies Breathe, newborn resuscitation, skills retention, mobile health, user-centred design
- Medical subject headings
- Asphyxia Neonatorum, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBB PromptBehavioural
Also called mobile app
Mobile app developed through user-centred design in phase 1 of this study
Low-Dose High Frequency trainingBehavioural
Also called LDHF
Participants will be encouraged to practice their HBB skills daily
| Study group | Role | What they receive |
|---|---|---|
| HBB Prompt | Experimental | The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together.
Providers at this hospital will have access to the most updated version of HBB Prompt (beta) after HBB training.
Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). The recommended frequency to use the app will be once per shift. Receives: Behavioral: HBB Prompt; Behavioral: Low-Dose High Frequency training |
| Control | Placebo comparator | The investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together.
The control group will not have exposure to the HBB Prompt app post training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). Receives: Behavioral: Low-Dose High Frequency training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score with 23 being the highest score. The OSCE B is a standard Helping Babies Breathe assessment tool that comprises the steps required in successfully assisting a neonate in its transition after birth
Measured: 12 months from initial HBB training
Secondary outcomes (13)
OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Measured: immediately before initial HBB training
OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Measured: immediately after initial HBB training
OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Measured: 3 months from initial HBB training
OSCE B score
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score
Measured: 6 months from initial HBB training
HBB 2.0 Knowledge Check
18 questions pertaining to newborn resuscitation
Measured: at unannounced visits within 12 months of training
Bag and mask ventilation skills check
evaluation of bagging skills to assist breathing - score out of 14
Measured: at unannounced visits within 12 months of training
Bag and mask ventilation quality measures with AIR Device
Augmented Infant Resuscitator (AIR) to objectively measure quality of newborn resuscitation during every ventilation epoch. AIR records time stamped data on ventilation quality, such as presence of air leak or obstruction and ventilation rate (www.air-device.com)
Measured: at unannounced visits within 12 months of training
OSCE A
standardized evaluation of resuscitation skills (slightly different scenario than for OSCE B), 9 out of 12 constitutes a pass score
Measured: at unannounced visits within 12 months of training
App analytics - pattern of usage
automated reports from the app regarding usage of different components of the app
Measured: during 12 months after initial training in intervention arm only
App analytics - frequency of usage
frequency of access to different parts of the app, duration of app usage
Measured: during 12 months after initial training in intervention arm only
App analytics - trends of performance
time trends of knowledge checks and simulation evaluations as noted in the app
Measured: during 12 months after initial training in intervention arm only
Frequency of practice
for both intervention and control arms, log-books will be reviewed for frequency of practice and in the intervention arm, this will be compared to what is reported through the app
Measured: during 12 months after initial training
Exit focus group feedback on barriers and facilitators to HBB training and skills maintenance
both intervention and control group participants will be interviewed to provide feedback on facilitators and barriers to HBB skills maintenance, and in the intervention arm, whether HBB Prompt helped or hindered their skills maintenance
Measured: at end of study (12 months from the start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start14 May 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Birth AsphyxiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Sponsor
- Investigators
- Santorino Data, MBChB, MMed, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577054
- Sponsor's protocol ID
- MUST 16/09-17
- Acronym
- HBB-Prompt
- Status last verified
- Jul 2018
- First submitted
- 15 May 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Msemo G, Massawe A, Mmbando D, Rusibamayila N, Manji K, Kidanto HL, Mwizamuholya D, Ringia P, Ersdal HL, Perlman J. Newborn mortality and fresh stillbirth rates in Tanzania after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e353-60. doi: 10.1542/peds.2012-1795. Epub 2013 Jan 21.
PubMed 23339223Kc A, Wrammert J, Clark RB, Ewald U, Vitrakoti R, Chaudhary P, Pun A, Raaijmakers H, Malqvist M. Reducing Perinatal Mortality in Nepal Using Helping Babies Breathe. Pediatrics. 2016 Jun;137(6):e20150117. doi: 10.1542/peds.2015-0117.
PubMed 27225317Goudar SS, Somannavar MS, Clark R, Lockyer JM, Revankar AP, Fidler HM, Sloan NL, Niermeyer S, Keenan WJ, Singhal N. Stillbirth and newborn mortality in India after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e344-52. doi: 10.1542/peds.2012-2112. Epub 2013 Jan 21.
PubMed 23339215Bang A, Patel A, Bellad R, Gisore P, Goudar SS, Esamai F, Liechty EA, Meleth S, Goco N, Niermeyer S, Keenan W, Kamath-Rayne BD, Little GA, Clarke SB, Flanagan VA, Bucher S, Jain M, Mujawar N, Jain V, Rukunga J, Mahantshetti N, Dhaded S, Bhandankar M, McClure EM, Carlo WA, Wright LL, Hibberd PL. Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time? BMC Pregnancy Childbirth. 2016 Nov 22;16(1):364. doi: 10.1186/s12884-016-1141-3.
PubMed 27875999Reisman J, Arlington L, Jensen L, Louis H, Suarez-Rebling D, Nelson BD. Newborn Resuscitation Training in Resource-Limited Settings: A Systematic Literature Review. Pediatrics. 2016 Aug;138(2):e20154490. doi: 10.1542/peds.2015-4490. Epub 2016 Jul 7.
PubMed 27388500Mduma E, Ersdal H, Svensen E, Kidanto H, Auestad B, Perlman J. Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation. 2015 Aug;93:1-7. doi: 10.1016/j.resuscitation.2015.04.019. Epub 2015 May 6.
PubMed 25957942Arabi AM, Ibrahim SA, Ahmed SE, MacGinnea F, Hawkes G, Dempsey E, Ryan CA. Skills retention in Sudanese village midwives 1 year following Helping Babies Breathe training. Arch Dis Child. 2016 May;101(5):439-42. doi: 10.1136/archdischild-2015-309190. Epub 2016 Jan 29.
PubMed 26826172Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
PubMed 26473001FDIs, I. (2009). 9241-210 (2009). Ergonomics of human system interaction-Part 210: Human-centered design for interactive systems (formerly known as 13407). International Organization for Standardization (ISO). Switzerland.
Krueger RA, Casey MA. Focus Groups: A practical guide for applied research. 4th ed. California: Sage Publications Inc., 2008.
Chan NH, Merali HS, Mistry N, Kealey R, Campbell DM, Morris SK, Data S. Development of a novel mobile application, HBB Prompt, with human factors and user-centred design for Helping Babies Breathe skills retention in Uganda. BMC Med Inform Decis Mak. 2021 Feb 4;21(1):39. doi: 10.1186/s12911-021-01406-z.
PubMed 33541340Merali HS, Chan NH, Mistry N, Kealey R, Campbell D, Morris SK, Data S. Designing and evaluating a novel mobile application for Helping Babies Breathe skills retention in Uganda: comparative study protocol. BMJ Paediatr Open. 2019 Sep 3;3(1):e000561. doi: 10.1136/bmjpo-2019-000561. eCollection 2019.
PubMed 31549001
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mobile Application Through User Centered Design to Improve Helping Babies Breath Skills Retention
- ClinicalTrials.gov ID
- NCT03577054
- Acronym / sponsor ID
- HBB-Prompt / MUST 16/09-17
- Conditions
- Birth Asphyxia, Neonatal Death
- Keywords
- Helping Babies Breathe, newborn resuscitation, skills retention, mobile health, user-centred design
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 5 Jul 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.
This study applies an iterative user-centred design approach involving frontline birth attendants to create a mobile application ("HBB Prompt") to improve skills retention after initial newborn stabilization training through the Helping Babies Breathe (HBB) program. HBB Prompt will then be piloted at one site after HBB training and skills retention will be compared with a control site without HBB Prompt after HBB training.
Detailed description
Helping Babies Breathe (HBB) is a newborn stabilization course that has been shown to reduce neonatal mortality by up to 47%. Such mortality impact is however not sustained due to rapid skills deterioration.
The investigators propose to improve sustainability of HBB's impact by increasing skills retention with an innovative mobile application called HBB Prompt. HBB Prompt will be an interactive tool that guides frontline providers through the steps needed to save newborn babies at birth. HBB Prompt will facilitate individual and group training in health facilities using the Low Dose High Frequency model (LDHF) for resuscitation skills retention.
The investigators will robustly develop HBB Prompt by integrating human factors and user-centered design approaches. The investigators will engage end-users and HBB Master Trainers to iteratively collect feedback to develop HBB Prompt for both individual and small group resuscitation practice. The iterative approach will mitigate the common scenario of mobile health (mHealth) solutions unable to achieve sustained success at scale due to lack of comprehensive input from frontline users.
The investigators will pilot the app at a single centre and compare it to a control site for HBB skills retention at different time points after initial HBB training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| HBB Prompt | Experimental | Behavioral: HBB Prompt, Behavioral: Low-Dose High Frequency trainingThe investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. Providers at this hospital will have access to the most updated version of HBB Prompt (beta) after HBB training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). The recommended frequency to use the app will be once per shift. |
| Control | Placebo comparator | Behavioral: Low-Dose High Frequency trainingThe investigators will train frontline health providers in Helping Babies Breathe (HBB) 2.0 and Essential Care for Every Baby (ECEB). Providers will undergo ECEB training in addition to HBB as these training programs are recommended by the Uganda Ministry of Health to be offered together. The control group will not have exposure to the HBB Prompt app post training. Participants in will be asked to achieve a minimum practice target of once per day (low-dose high frequency training). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Frontline birth attendants involved in the delivery or care of babies in the maternity ward, theater or pediatric wards with a possibility of involvement in newborn resuscitation.
Key exclusion criteria (1 listed)
- Health workers providing care in other wards other than maternity and pediatrics.
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 |
|---|---|---|
| HBB PromptAlso: mobile appMobile app developed through user-centred design in phase 1 of this study | Behavioural | HBB Prompt |
| Low-Dose High Frequency trainingAlso: LDHFParticipants will be encouraged to practice their HBB skills daily | Behavioural | Control, HBB Prompt |
Primary outcome
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score
Time frame: 12 months from initial HBB training
standardized comprehensive evaluation of HBB skills, 17 out of 23 constitutes a pass score with 23 being the highest score. The OSCE B is a standard Helping Babies Breathe assessment tool that comprises the steps required in successfully assisting a neonate in its transition after birth
13 secondary outcomes
OSCE B score
Time frame: immediately before initial HBB training
OSCE B score
Time frame: immediately after initial HBB training
OSCE B score
Time frame: 3 months from initial HBB training
OSCE B score
Time frame: 6 months from initial HBB training
HBB 2.0 Knowledge Check
Time frame: at unannounced visits within 12 months of training
Bag and mask ventilation skills check
Time frame: at unannounced visits within 12 months of training
Bag and mask ventilation quality measures with AIR Device
Time frame: at unannounced visits within 12 months of training
OSCE A
Time frame: at unannounced visits within 12 months of training
App analytics - pattern of usage
Time frame: during 12 months after initial training in intervention arm only
App analytics - frequency of usage
Time frame: during 12 months after initial training in intervention arm only
App analytics - trends of performance
Time frame: during 12 months after initial training in intervention arm only
Frequency of practice
Time frame: during 12 months after initial training
Exit focus group feedback on barriers and facilitators to HBB training and skills maintenance
Time frame: at end of study (12 months from the start)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 23339223Msemo G, Massawe A, Mmbando D, Rusibamayila N, Manji K, Kidanto HL, Mwizamuholya D, Ringia P, Ersdal HL, Perlman J. Newborn mortality and fresh stillbirth rates in Tanzania after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e353-60. doi: 10.1542/peds.2012-1795. Epub 2013 Jan 21.
- Background: PubMed 27225317Kc A, Wrammert J, Clark RB, Ewald U, Vitrakoti R, Chaudhary P, Pun A, Raaijmakers H, Malqvist M. Reducing Perinatal Mortality in Nepal Using Helping Babies Breathe. Pediatrics. 2016 Jun;137(6):e20150117. doi: 10.1542/peds.2015-0117.
- Background: PubMed 23339215Goudar SS, Somannavar MS, Clark R, Lockyer JM, Revankar AP, Fidler HM, Sloan NL, Niermeyer S, Keenan WJ, Singhal N. Stillbirth and newborn mortality in India after helping babies breathe training. Pediatrics. 2013 Feb;131(2):e344-52. doi: 10.1542/peds.2012-2112. Epub 2013 Jan 21.
- Background: PubMed 27875999Bang A, Patel A, Bellad R, Gisore P, Goudar SS, Esamai F, Liechty EA, Meleth S, Goco N, Niermeyer S, Keenan W, Kamath-Rayne BD, Little GA, Clarke SB, Flanagan VA, Bucher S, Jain M, Mujawar N, Jain V, Rukunga J, Mahantshetti N, Dhaded S, Bhandankar M, McClure EM, Carlo WA, Wright LL, Hibberd PL. Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time? BMC Pregnancy Childbirth. 2016 Nov 22;16(1):364. doi: 10.1186/s12884-016-1141-3.
- Background: PubMed 27388500Reisman J, Arlington L, Jensen L, Louis H, Suarez-Rebling D, Nelson BD. Newborn Resuscitation Training in Resource-Limited Settings: A Systematic Literature Review. Pediatrics. 2016 Aug;138(2):e20154490. doi: 10.1542/peds.2015-4490. Epub 2016 Jul 7.
- Background: PubMed 25957942Mduma E, Ersdal H, Svensen E, Kidanto H, Auestad B, Perlman J. Frequent brief on-site simulation training and reduction in 24-h neonatal mortality--an educational intervention study. Resuscitation. 2015 Aug;93:1-7. doi: 10.1016/j.resuscitation.2015.04.019. Epub 2015 May 6.
- Background: PubMed 26826172Arabi AM, Ibrahim SA, Ahmed SE, MacGinnea F, Hawkes G, Dempsey E, Ryan CA. Skills retention in Sudanese village midwives 1 year following Helping Babies Breathe training. Arch Dis Child. 2016 May;101(5):439-42. doi: 10.1136/archdischild-2015-309190. Epub 2016 Jan 29.
- Background: PubMed 26473001Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
- BackgroundFDIs, I. (2009). 9241-210 (2009). Ergonomics of human system interaction-Part 210: Human-centered design for interactive systems (formerly known as 13407). International Organization for Standardization (ISO). Switzerland.
- BackgroundKrueger RA, Casey MA. Focus Groups: A practical guide for applied research. 4th ed. California: Sage Publications Inc., 2008.
- Derived from this study: PubMed 33541340Chan NH, Merali HS, Mistry N, Kealey R, Campbell DM, Morris SK, Data S. Development of a novel mobile application, HBB Prompt, with human factors and user-centred design for Helping Babies Breathe skills retention in Uganda. BMC Med Inform Decis Mak. 2021 Feb 4;21(1):39. doi: 10.1186/s12911-021-01406-z.
- Derived from this study: PubMed 31549001Merali HS, Chan NH, Mistry N, Kealey R, Campbell D, Morris SK, Data S. Designing and evaluating a novel mobile application for Helping Babies Breathe skills retention in Uganda: comparative study protocol. BMJ Paediatr Open. 2019 Sep 3;3(1):e000561. doi: 10.1136/bmjpo-2019-000561. eCollection 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Birth Asphyxia
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
RecruitingPhase 2
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Neonatal Encephalopathy
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.
Santorino Data, MBChB, MMed principal investigator
Mbarara University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBB Prompt and Low-Dose High Frequency training in people with Birth Asphyxia and Neonatal Death, run by Mbarara University of Science and Technology at 1 site in Uganda.
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 1 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 6 Jul 2018. 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 Uganda. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francis Bajunirwe, PhD (+256772576396, fbaj@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helping Babies Breathe Objective Structured Clinical Exam (OSCE) B score (time frame: 12 months from initial HBB training). 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 NCT03577054, which also lists 12 linked publications.
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 6 Jul 2018.