SepsisNCT00518609
Prevention of Infection in Indian Neonates - Phase I Observational Study
An observational study of Sepsis, run by NICHD Global Network for Women's and Children's Health at 3 sites in India.
Trial summary
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. Read more about this study
- Who is it for?
- Ages Up to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 1,326 participants
- Where
- 3 sitesIndia
- Study dates
- Jul 2003to Jul 2006
- Phase
- Observational
- 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 Up to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age <60 days
- A diagnosis of suspected sepsis/pneumonia, based on the presence of at least one of the following symptoms at admission: poor feeding/poor sucking, decreased activity/lethargy, fever, hypothermia, cyanosis, diarrhea, abdominal distension, seizures, apneic spells, sclerema, bleeding, jaundice, tachypnea, chest wall retractions, shock.
- Born in one of the participating hospitals or in village inside catchment area If the screening physician does not suspect sepsis, even in the presence of one or more of the above signs, the baby should not be enrolled.
Who cannot join
- The presence of major congenital anomalies A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Capital Hospital
Bhubaneswar, Odisha
Kalinga Hospital
Bhubaneswar, Odisha
Ispat General Hospital
Rourkela, Odisha
About this study
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
Read the detailed description
Invasive bacterial infections encompass clinical diagnoses of septicemia, pneumonia, and meningitis. Together, these infections are termed "neonatal sepsis" and account for over half of the newborn deaths at the district and sub-district level in India. Sepsis is the most common (80-90 percent) primary diagnosis for admission in Indian hospitals. Phase 1 of this study is a prospective, epidemiologic study involving over 1,000 community-based and hospital populations of newborn infants. It includes identifying all infants born in study hospitals and those brought to the hospitals with suspected sepsis; obtaining blood cultures from these infants and identifying the sepsis-causing bacteria; screening of all bacterial strains isolated from blood cultures for antimicrobial resistance; collecting basic demographic, risk factor, and treatment data on each case; and developing a computer-based system/network for data management. A village-level surveillance system was put in place to identify women during their pregnancy; monitor pregnancy outcomes; and establish a mechanism for referral of all potentially septic infants to participating clinics or hospitals for evaluation, including the collection of blood cultures. Potential sources of bacteria causing sepsis will be identified using molecular epidemiologic techniques. This involves matching septic infants' blood isolates with other colonizing isolates obtained from screening skin, throat, and stool cultures in the infant and skin and vaginal cultures from their mothers.
- Conditions
- Sepsis
- Keywords
- Neonatal, Sepsis, Global Network, Antibiotics, India, International, Maternal and child health
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Indian Neonates | All hospitalized neonates (all live born infants <60 days of age, independent of birth weight and gestational age) brought to hospital, with the diagnosis of suspected sepsis. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startJul 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, All India Institute of Medical Sciences, TN Medical College, Mumbai, Department of Health and Family Welfare, Orissa, SCB Medical College, Cuttack, Capital Hospital, Bhubaneswar, Ispat General Hospital, Rourkela, Kalinga Hospital, Bhubaneswar, University of Maryland
- Responsible party
- Sponsor
- Investigators
- Pinaki Panigrahi, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518609
- Sponsor's protocol ID
- GN 07 Phase I
- Other IDs
- U01HD040574
- Status last verified
- Jul 2014
- First submitted
- 20 Aug 2007
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- Prevention of Infection in Indian Neonates - Phase I Observational Study
- ClinicalTrials.gov ID
- NCT00518609
- Acronym / sponsor ID
- GN 07 Phase I
- Conditions
- Sepsis
- Keywords
- Neonatal, Sepsis, Global Network, Antibiotics, India, International, Maternal and child health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,326 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, All India Institute of Medical Sciences, TN Medical College, Mumbai, Department of Health and Family Welfare, Orissa, SCB Medical College, Cuttack, Capital Hospital, Bhubaneswar, Ispat General Hospital, Rourkela, Kalinga Hospital, Bhubaneswar, University of Maryland
- Study start
- Jul 2003
- Study completion
- Jul 2006 (actual)
- First posted
- 21 Aug 2007 (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.
India, with one of the world's largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Neonatal infection (sepsis) now accounts for 50 percent of deaths among community-born (and 20 percent of mortality among hospital-born) infants. This study is the first phase of a multi-phase project investigating interventions to prevent neonatal infection in India.
Detailed description
Invasive bacterial infections encompass clinical diagnoses of septicemia, pneumonia, and meningitis. Together, these infections are termed "neonatal sepsis" and account for over half of the newborn deaths at the district and sub-district level in India. Sepsis is the most common (80-90 percent) primary diagnosis for admission in Indian hospitals. Phase 1 of this study is a prospective, epidemiologic study involving over 1,000 community-based and hospital populations of newborn infants. It includes identifying all infants born in study hospitals and those brought to the hospitals with suspected sepsis; obtaining blood cultures from these infants and identifying the sepsis-causing bacteria; screening of all bacterial strains isolated from blood cultures for antimicrobial resistance; collecting basic demographic, risk factor, and treatment data on each case; and developing a computer-based system/network for data management. A village-level surveillance system was put in place to identify women during their pregnancy; monitor pregnancy outcomes; and establish a mechanism for referral of all potentially septic infants to participating clinics or hospitals for evaluation, including the collection of blood cultures. Potential sources of bacteria causing sepsis will be identified using molecular epidemiologic techniques. This involves matching septic infants' blood isolates with other colonizing isolates obtained from screening skin, throat, and stool cultures in the infant and skin and vaginal cultures from their mothers.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indian Neonates | – | –All hospitalized neonates (all live born infants <60 days of age, independent of birth weight and gestational age) brought to hospital, with the diagnosis of suspected sepsis. |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age <60 days
- A diagnosis of suspected sepsis/pneumonia, based on the presence of at least one of the following symptoms at admission: poor feeding/poor sucking, decreased activity/lethargy, fever, hypothermia, cyanosis, diarrhea, abdominal distension, seizures, apneic spells, sclerema, bleeding, jaundice, tachypnea, chest wall retractions, shock.
- Born in one of the participating hospitals or in village inside catchment area If the screening physician does not suspect sepsis, even in the presence of one or more of the above signs, the baby should not be enrolled.
Key exclusion criteria (1 listed)
- The presence of major congenital anomalies A major congenital anomaly is defined as any malformation that is felt to be life-threatening or that requires surgical intervention. If the medical officer is uncertain whether an anomaly is life-threatening, he/she should not enroll the infant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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.
- Global Network for Women's and Children's Health ResearchLink provided by the sponsor.
- RTI InternationalLink provided by the sponsor.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Pinaki Panigrahi, M.D. principal investigator
University of Maryland, Baltimore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by NICHD Global Network for Women's and Children's Health at 3 sites 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 3 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. 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.
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 31 Jul 2014.