Birth AsphyxiaAKUNCT01350765
Naushero Feroze Neonatal Survival Project
A study testing Intervention in people with Birth Asphyxia and Very Low Birth Weight Baby, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37,201 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2010to Jan 2013
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of ages 1 day to 28 days, within the catchment area of the preformed research.
Who cannot join
- Those who are not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naushero Feroze Neonatal Survival Project: A Cluster Randomized Trial to Determine the Effectiveness of Package of Community Based Interventions to Reduce Neonatal Deaths Due to Birth Asphyxia, Low Birth Weight & Neonatal Sepsis
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional Birth Attendant will provide care to the mothers and newborns at household level. A Basic Health Unit will take care of non complicated referrals and provide injectable antibiotics for neonatal sepsis. Complicated (definitions given in methods section) cases will be referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of Health, Sindh and the Federal Ministry of Health are study collaborators, therefore, guaranteeing scaling up of interventions at national level.
Hypothesis:
In comparison to a basic package of existing training program of LHWs, enhanced training of LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn infections and LBW (combined with prompt referral) will result in an additional 30% reduction in neonatal mortality.
Read the detailed description
The proposed body of work addresses important major determinants and immediate causes of neonatal mortality in Pakistan. The recent DHS survey indicates that three causes prematurity, birth asphyxia and serious infections account for approximately 85% of the burden of newborn deaths in Pakistan (PDHS 2007). The recent evidence base of interventions for neonatal interventions clearly indicates that the investigators have a basis for action and several interventions that can make a difference to outcomes. Several of these interventions are clearly feasible within the health system and a fundamental point would be the assurance of skilled care and services for newborn resuscitation, basic preterm care and management of referred cases with neonatal infections within the health facilities (RHCs, THQ and DHQ hospitals in the catchment district). However, given the fact that the vast majority of neonatal birth and deaths still occur in community settings, the added value is the implementation of relevant interventions in community settings. To illustrate, the figure below indicates the potential interventions, links between them and pathways for reduction in the exposure to and adverse outcomes from neonatal sepsis. Although the algorithm suggests that severe neonatal infections should be referred for further care in facility settings, it is recognized that in some situations where care seeking may neither be possible nor feasible, treatment for neonatal sepsis may need to be provided at domiciliary or community level (i.e. through community based clinics or BHUs).
Research questions
Can a package of community-based interventions, linked to strengthened health facilities, reduce NMR and be feasibly delivered, with interventions focused on training TBAs \& LHWs to be linked such that LHWs recognize and provide immediate/early management of the newborn complications - birth asphyxia, serious newborn infection, and low birth weight, in tandem with TBAs?
Can these community-based cadres of care providers improve and sustain skills for the provision of quality care for newborn complications of birth asphyxia, serious newborn infection, and low birth weight?
Can community-based strategies of training TBAs and LHWs, and mobilizing communities to focus on perinatal health, result in improved knowledge and use of key newborn health practices related to prevention of newborn complications such as birth asphyxia, serious newborn infections, and complications low birth weight?
Primary Objectives:
To develop and implement intervention packages for TBAs and LHWs to reduce the burden of birth asphyxia, sepsis and low birth weight and asses their feasibility for potential scale up
To assess the efficacy of this intervention package in reducing all cause neonatal mortality at population level
Secondary Objectives:
To improve case recognition and management of birth asphyxia, sepsis and LBW by primary care health care providers (in both the public and private sector such as Midwives, LHWs and TBAs) in primary care settings.
To evaluate the combined effectiveness of birth asphyxia, sepsis and low birth weight interventions delivered by TBAs and LHWs on cause specific neonatal mortality at population level.
To evaluate the effectiveness of using the enhanced intervention package to enhance collaboration and linkages between LHWs and TBAs and to increase LHW attendance during home deliveries.
- Conditions
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- Being tested
- Intervention, Control
- Keywords
- Birth asphyxia, Low birth weight, neonatal sepsis, mortality, community based interventions
- Medical subject headings
- Asphyxia Neonatorum, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
The LHWs of the selected intervention areas would receive additional training on ENC for identification, management and referral for birth asphyxia, lbw and neonatal sepsis.
ControlBehavioural
The LHWs in the control areas would perform their routine tasks as assigned to them by their program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This would be the interventional arm of the study, where the LHWs would receive additional training for identification and management of birth asphyxia, lbw, and sepsis. Receives: Behavioral: Intervention |
| Control | Active comparator | This would be the comparative group of the study in which the LHWs would perform the usual routine tasks assigned to them by their program. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
neonatal mortality rate Perinatal mortality rates Neonatal mortality rates
the subjects from the two arms would be inquired on information pertaining to socioeconomic position, health services, behaviors and morbibity/ mortality. in view of the most reported concern in the previous studies is noenatal mortality, that information will be primarily important for this research.
Measured: two year
Secondary outcomes (1)
Cause specific mortality rates (due to birth asphyxia,neonatal sepsis and low birth weight)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startMar 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37,201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children, Pakistan Ministry of Health
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Sajid B Soofi, MBBS, FCPS, Study director, Aga Khan UniversityZulfiqar A Bhutta, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350765
- Sponsor's protocol ID
- 1212-Ped/ERC
- Acronym
- AKU
- Status last verified
- Jan 2018
- First submitted
- 9 May 2011
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naushero Feroze Neonatal Survival Project: A Cluster Randomized Trial to Determine the Effectiveness of Package of Community Based Interventions to Reduce Neonatal Deaths Due to Birth Asphyxia, Low Birth Weight & Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT01350765
- Acronym / sponsor ID
- AKU / 1212-Ped/ERC
- Conditions
- Birth Asphyxia, Very Low Birth Weight Baby, Neonatal Sepsis
- Keywords
- Birth asphyxia, Low birth weight, neonatal sepsis, mortality, community based interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37,201 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Save the Children, Pakistan Ministry of Health
- Study start
- Mar 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 May 2011 (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.
The present study will be carried out in close collaboration with the National Program for Lady Health Workers, a Ministry of Health program with 100,000 Lady Health Workers covering 60% of the rural population of Pakistan. A team of Lady Health Workers and a Traditional Birth Attendant will provide care to the mothers and newborns at household level. A Basic Health Unit will take care of non complicated referrals and provide injectable antibiotics for neonatal sepsis. Complicated (definitions given in methods section) cases will be referred by the LHWs/BHUs to the District Headquarter Hospital which will have a functioning neonatal care unit. The District Health Services, Naushero Feroz, Provincial Department of Health, Sindh and the Federal Ministry of Health are study collaborators, therefore, guaranteeing scaling up of interventions at national level.
Hypothesis:
In comparison to a basic package of existing training program of LHWs, enhanced training of LHWs and TBAs in the early recognition and management of birth asphyxia, serious newborn infections and LBW (combined with prompt referral) will result in an additional 30% reduction in neonatal mortality.
Detailed description
The proposed body of work addresses important major determinants and immediate causes of neonatal mortality in Pakistan. The recent DHS survey indicates that three causes prematurity, birth asphyxia and serious infections account for approximately 85% of the burden of newborn deaths in Pakistan (PDHS 2007). The recent evidence base of interventions for neonatal interventions clearly indicates that the investigators have a basis for action and several interventions that can make a difference to outcomes. Several of these interventions are clearly feasible within the health system and a fundamental point would be the assurance of skilled care and services for newborn resuscitation, basic preterm care and management of referred cases with neonatal infections within the health facilities (RHCs, THQ and DHQ hospitals in the catchment district). However, given the fact that the vast majority of neonatal birth and deaths still occur in community settings, the added value is the implementation of relevant interventions in community settings. To illustrate, the figure below indicates the potential interventions, links between them and pathways for reduction in the exposure to and adverse outcomes from neonatal sepsis. Although the algorithm suggests that severe neonatal infections should be referred for further care in facility settings, it is recognized that in some situations where care seeking may neither be possible nor feasible, treatment for neonatal sepsis may need to be provided at domiciliary or community level (i.e. through community based clinics or BHUs).
Research questions
Can a package of community-based interventions, linked to strengthened health facilities, reduce NMR and be feasibly delivered, with interventions focused on training TBAs \& LHWs to be linked such that LHWs recognize and provide immediate/early management of the newborn complications - birth asphyxia, serious newborn infection, and low birth weight, in tandem with TBAs?
Can these community-based cadres of care providers improve and sustain skills for the provision of quality care for newborn complications of birth asphyxia, serious newborn infection, and low birth weight?
Can community-based strategies of training TBAs and LHWs, and mobilizing communities to focus on perinatal health, result in improved knowledge and use of key newborn health practices related to prevention of newborn complications such as birth asphyxia, serious newborn infections, and complications low birth weight?
Primary Objectives:
To develop and implement intervention packages for TBAs and LHWs to reduce the burden of birth asphyxia, sepsis and low birth weight and asses their feasibility for potential scale up
To assess the efficacy of this intervention package in reducing all cause neonatal mortality at population level
Secondary Objectives:
To improve case recognition and management of birth asphyxia, sepsis and LBW by primary care health care providers (in both the public and private sector such as Midwives, LHWs and TBAs) in primary care settings.
To evaluate the combined effectiveness of birth asphyxia, sepsis and low birth weight interventions delivered by TBAs and LHWs on cause specific neonatal mortality at population level.
To evaluate the effectiveness of using the enhanced intervention package to enhance collaboration and linkages between LHWs and TBAs and to increase LHW attendance during home deliveries.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThis would be the interventional arm of the study, where the LHWs would receive additional training for identification and management of birth asphyxia, lbw, and sepsis. |
| Control | Active comparator | Behavioral: ControlThis would be the comparative group of the study in which the LHWs would perform the usual routine tasks assigned to them by their program. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of ages 1 day to 28 days, within the catchment area of the preformed research.
Key exclusion criteria (1 listed)
- Those who are not willing to participate in the study.
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 |
|---|---|---|
| InterventionThe LHWs of the selected intervention areas would receive additional training on ENC for identification, management and referral for birth asphyxia, lbw and neonatal sepsis. | Behavioural | Intervention |
| ControlThe LHWs in the control areas would perform their routine tasks as assigned to them by their program | Behavioural | Control |
Primary outcome
neonatal mortality rate Perinatal mortality rates Neonatal mortality rates
Time frame: two year
the subjects from the two arms would be inquired on information pertaining to socioeconomic position, health services, behaviors and morbibity/ mortality. in view of the most reported concern in the previous studies is noenatal mortality, that information will be primarily important for this research.
1 secondary outcome
Cause specific mortality rates (due to birth asphyxia,neonatal sepsis and low birth weight)
Time frame: two years
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 10 Jan 2018.
- Individual participant dataSharing planned: Yes
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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.
Sajid B Soofi, MBBS, FCPS study director
Aga Khan University
Zulfiqar A Bhutta, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Birth Asphyxia and Very Low Birth Weight Baby, run by Aga Khan University at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 10 Jan 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 Pakistan. 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?
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?
neonatal mortality rate Perinatal mortality rates Neonatal mortality rates (time frame: two 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 10 Jan 2018.