AsphyxiaPhase 4BRAIN-HITNCT00639184
BRAIN - Home Intervention Trial
A Phase 4 study testing Early intervention counseling and Health education counseling in people with Asphyxia, run by NICHD Global Network for Women's and Children's Health at 3 sites in 3 countries.
Trial summary
We plan to test a home-based parent-provided early developmental intervention (EI) both in infants with mild to moderate birth asphyxia and in infants without perinatal complications who will constitute a healthy comparison group in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 1 minute to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Asphyxia
- What is being tested?
- Early intervention counseling and Health education counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2007to Jun 2010
- Phase
- Phase 4
- 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 minute to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- birth asphyxia
- birth weight of at least 1,500g
- neurological examination consistent with normal, Stage I or II on the Ellis scale (Ellis, et al. 2000)
- willing to participate in an intervention program for 36 months.
Who cannot join
- -
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Brain Research to Ameliorate Impaired Neurodevelopment (BRAIN): Home-based Intervention A Multicenter Trial of the Global Network for Women's and Children's Health Research
We plan to test a home-based parent-provided early developmental intervention (EI) both in infants with mild to moderate birth asphyxia and in infants without perinatal complications who will constitute a healthy comparison group in a randomized controlled trial. The trial will evaluate the effect of a resource-intensive early intervention (EI) program on the outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third years) between parents and the parent trainer. The control group will receive enhanced health counseling (HC).
The overall goal will be to implement and evaluate an EI program for infants following birth asphyxia, which is sustainable in developing countries. The challenge will be to adapt programs demonstrated to be effective in developed countries to the circumstances of the developing world, while reducing the demands on resources. Because there are limited data on normative development and EI programs in developing countries, a group of infants without perinatal complications will also be randomized to the same conditions in order to provide a comparison of what may be achieved from the intervention in healthy infants in developing countries. A final aim will be to address individual variation in EI effects that could be due to child and/or family characteristics.
A randomized controlled experimental design will be used, in which infants who survive following birth asphyxia are randomly assigned to either EI or enhanced health education counseling (HC). The trial will randomize infants to a home-based parent-provided early developmental intervention (EI) with frequent home interaction between parents and parent trainers vs. HC. A group of infants without birth asphyxia or other major perinatal complications also will be randomized. Children will be examined by masked examiners at three time points (12, 24, and 36 month's assessments).
- Conditions
- Asphyxia
- Being tested
- Early intervention counseling, Health education counseling
- Keywords
- asphyxia, neurodevelopmental outcome, home counseling
- Medical subject headings
- Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intervention counselingOther
Bi-monthly home visits by counselor
Health education counselingOther
World Health Education health education counseling program at home visits,twice per month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Home intervention program Receives: Other: Early intervention counseling |
| 2 | Active comparator | health education counseling Receives: Other: Health education counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurodevelopmental outcome
Measured: 36 months
Secondary outcomes (2)
The improvements in cognitive, social, and motor development will be larger in the infants who have had birth asphyxia compared to those without birth asphyxia.
Measured: 12, 24 and 36 months
The effects of EI in infants with and without birth asphyxia will be moderated by child and family characteristics.
Measured: 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marion Koso-Thomas, MD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Wally A Carlo, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639184
- Sponsor's protocol ID
- CP04
- Other IDs
- HD 40636
- Acronym
- BRAIN-HIT
- Status last verified
- Jul 2014
- First submitted
- 18 Mar 2008
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carlo WA, Goudar SS, Pasha O, Chomba E, McClure EM, Biasini FJ, Wallander JL, Thorsten V, Chakraborty H, Wright LL; Brain Research to Ameliorate Impaired Neurodevelopment-Home-based Intervention Trial Committee; National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research. Neurodevelopmental outcomes in infants requiring resuscitation in developing countries. J Pediatr. 2012 May;160(5):781-5.e1. doi: 10.1016/j.jpeds.2011.10.007. Epub 2011 Nov 17.
PubMed 22099522Wallander JL, McClure E, Biasini F, Goudar SS, Pasha O, Chomba E, Shearer D, Wright L, Thorsten V, Chakraborty H, Dhaded SM, Mahantshetti NS, Bellad RM, Abbasi Z, Carlo W; BRAIN-HIT Investigators. Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT). BMC Pediatr. 2010 Apr 30;10:27. doi: 10.1186/1471-2431-10-27.
PubMed 20433740
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Research to Ameliorate Impaired Neurodevelopment (BRAIN): Home-based Intervention A Multicenter Trial of the Global Network for Women's and Children's Health Research
- ClinicalTrials.gov ID
- NCT00639184
- Acronym / sponsor ID
- BRAIN-HIT / CP04
- Conditions
- Asphyxia
- Keywords
- asphyxia, neurodevelopmental outcome, home counseling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Study start
- Jun 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Mar 2008 (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.
We plan to test a home-based parent-provided early developmental intervention (EI) both in infants with mild to moderate birth asphyxia and in infants without perinatal complications who will constitute a healthy comparison group in a randomized controlled trial. The trial will evaluate the effect of a resource-intensive early intervention (EI) program on the outcomes in infants born in rural communities in Zambia, India, and Pakistan. It will consist of frequent interaction (every 2 weeks the first year and every 4 weeks the second and third years) between parents and the parent trainer. The control group will receive enhanced health counseling (HC).
The overall goal will be to implement and evaluate an EI program for infants following birth asphyxia, which is sustainable in developing countries. The challenge will be to adapt programs demonstrated to be effective in developed countries to the circumstances of the developing world, while reducing the demands on resources. Because there are limited data on normative development and EI programs in developing countries, a group of infants without perinatal complications will also be randomized to the same conditions in order to provide a comparison of what may be achieved from the intervention in healthy infants in developing countries. A final aim will be to address individual variation in EI effects that could be due to child and/or family characteristics.
A randomized controlled experimental design will be used, in which infants who survive following birth asphyxia are randomly assigned to either EI or enhanced health education counseling (HC). The trial will randomize infants to a home-based parent-provided early developmental intervention (EI) with frequent home interaction between parents and parent trainers vs. HC. A group of infants without birth asphyxia or other major perinatal complications also will be randomized. Children will be examined by masked examiners at three time points (12, 24, and 36 month's assessments).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Early intervention counselingHome intervention program |
| 2 | Active comparator | Other: Health education counselinghealth education counseling |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- birth asphyxia
- birth weight of at least 1,500g
- neurological examination consistent with normal, Stage I or II on the Ellis scale (Ellis, et al. 2000)
- willing to participate in an intervention program for 36 months.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Early intervention counselingBi-monthly home visits by counselor | Other | 1 |
| Health education counselingWorld Health Education health education counseling program at home visits,twice per month | Other | 2 |
Primary outcome
neurodevelopmental outcome
Time frame: 36 months
2 secondary outcomes
The improvements in cognitive, social, and motor development will be larger in the infants who have had birth asphyxia compared to those without birth asphyxia.
Time frame: 12, 24 and 36 months
The effects of EI in infants with and without birth asphyxia will be moderated by child and family characteristics.
Time frame: 12, 24 and 36 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 31 Jul 2014.
- Derived from this study: PubMed 22099522Carlo WA, Goudar SS, Pasha O, Chomba E, McClure EM, Biasini FJ, Wallander JL, Thorsten V, Chakraborty H, Wright LL; Brain Research to Ameliorate Impaired Neurodevelopment-Home-based Intervention Trial Committee; National Institute of Child Health and Human Development Global Network for Women's and Children's Health Research. Neurodevelopmental outcomes in infants requiring resuscitation in developing countries. J Pediatr. 2012 May;160(5):781-5.e1. doi: 10.1016/j.jpeds.2011.10.007. Epub 2011 Nov 17.
- Derived from this study: PubMed 20433740Wallander JL, McClure E, Biasini F, Goudar SS, Pasha O, Chomba E, Shearer D, Wright L, Thorsten V, Chakraborty H, Dhaded SM, Mahantshetti NS, Bellad RM, Abbasi Z, Carlo W; BRAIN-HIT Investigators. Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT). BMC Pediatr. 2010 Apr 30;10:27. doi: 10.1186/1471-2431-10-27.
Related trials for Asphyxia
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Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
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Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
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Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Neonatal Encephalopathy
Not yet recruiting
Multimodal Analysis of Early Biomarkers of the Impacts of Perinatal Asphyxia
Neonate, Asphyxia
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.
Marion Koso-Thomas, MD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Wally A Carlo principal investigator
University of Alabama at Birmingham
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early intervention counseling and Health education counseling in people with Asphyxia, run by NICHD Global Network for Women's and Children's Health at 3 sites in 3 countries.
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 4 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 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India, Pakistan, Zambia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
neurodevelopmental outcome (time frame: 36 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 NCT00639184, which also lists 2 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 31 Jul 2014.