Pregnancy ComplicationsNCT00198887
Operations Research to Improve Newborn Health
A study testing Operations research in people with Pregnancy Complications, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.
Trial summary
This study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in India. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Operations research
- Type of treatment
- Surgery or procedure
- How many people
- 59,651 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2003to Oct 2006
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Newborn
Who cannot join
- Infant/child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Operations Research to Improve Newborn Health and Survival in the (INHP-II) Area of CARE/India
This study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in India.
Read the detailed description
The proposed study aims to evaluate the impact of a basic package of obstetric and neonatal care practices implemented by CARE-India as part of their ten-year, two-phase Integrated Nutrition and Health Program (INHP). Building on the lessons learned from the Integrated Nutrition and Health Project I (INHP I) in seven Indian states during 1996-2001, CARE-India has designed INHP II, which focuses on six technical interventions. CARE-India aims to implement this program in 100,000 villages across eight states of India by the year 2006. One of the technical interventions is a focused package of newborn care to be implemented at the community level to improve the health and survival of the newborns, including improvements in care-seeking for maternal and newborn conditions. The services and behaviors promoted include:
- antenatal care,
- iron-folate supplementation,
- tetanus toxoid vaccination,
- maternal nutrition and rest,
- birth planning,
- essential newborn care,
- immediate and exclusive breastfeeding,
- prevention of hypothermia,
- aseptic cord care, and
- identification and referral of cases with danger signs for both pregnancy/delivery complications and newborn conditions.
The services are provided by first-line community-based health workers.
CARE-India invited Johns Hopkins Bloomberg School of Public Health (JHBSPH) to help evaluate their newborn program in an operations research mode. JHBSPH's role is limited to assisting CARE with the design and evaluation of newborn intervention.
- Conditions
- Pregnancy Complications
- Being tested
- Operations research
- Keywords
- newborn, operations research, newborn survival, Neonatal illness/mortality, Delivery complications
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operations researchProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal mortality rate
Secondary outcomes (3)
Cost of delivering the intervention, per newborn
Changes in behavioral indicators
Change in program coverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2003
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59,651 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Investigators
- Mathuram Santosham, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198887
- Sponsor's protocol ID
- H.22.02.08.30.A2
- Status last verified
- Jul 2007
- First submitted
- 12 Sep 2005
- Last updated
- 6 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operations Research to Improve Newborn Health and Survival in the (INHP-II) Area of CARE/India
- ClinicalTrials.gov ID
- NCT00198887
- Acronym / sponsor ID
- H.22.02.08.30.A2
- Conditions
- Pregnancy Complications
- Keywords
- newborn, operations research, newborn survival, Neonatal illness/mortality, Delivery complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59,651 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Sep 2005 (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.
This study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in India.
Detailed description
The proposed study aims to evaluate the impact of a basic package of obstetric and neonatal care practices implemented by CARE-India as part of their ten-year, two-phase Integrated Nutrition and Health Program (INHP). Building on the lessons learned from the Integrated Nutrition and Health Project I (INHP I) in seven Indian states during 1996-2001, CARE-India has designed INHP II, which focuses on six technical interventions. CARE-India aims to implement this program in 100,000 villages across eight states of India by the year 2006. One of the technical interventions is a focused package of newborn care to be implemented at the community level to improve the health and survival of the newborns, including improvements in care-seeking for maternal and newborn conditions. The services and behaviors promoted include:
- antenatal care,
- iron-folate supplementation,
- tetanus toxoid vaccination,
- maternal nutrition and rest,
- birth planning,
- essential newborn care,
- immediate and exclusive breastfeeding,
- prevention of hypothermia,
- aseptic cord care, and
- identification and referral of cases with danger signs for both pregnancy/delivery complications and newborn conditions.
The services are provided by first-line community-based health workers.
CARE-India invited Johns Hopkins Bloomberg School of Public Health (JHBSPH) to help evaluate their newborn program in an operations research mode. JHBSPH's role is limited to assisting CARE with the design and evaluation of newborn intervention.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Newborn
Key exclusion criteria (1 listed)
- Infant/child
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 |
|---|---|---|
| Operations research | Procedure or surgery | – |
Primary outcome
Neonatal mortality rate
3 secondary outcomes
Cost of delivering the intervention, per newborn
Changes in behavioral indicators
Change in program coverage
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 6 Jul 2007.
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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.
Mathuram Santosham, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operations research in people with Pregnancy Complications, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.
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 6 Jul 2007. 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 India. 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. 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 6 Jul 2007.