OmphalitisPhase 3ChlorhexidineNCT00682006
Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan
A Phase 3 study testing 4% Chlorhexidine and Hand washing Soap in people with Omphalitis, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Omphalitis
- What is being tested?
- 4% Chlorhexidine and Hand washing Soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,800 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 3
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All healthy newborns, born in the study setting will be systematically enrolled in the trial
Who cannot join
- Infants with congenital/birth defects
- Infants with any localized infection on the peri-umbilical region at the time of birth or application of any other material such as dung, etc before enrollment on the Cord.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan: A Community-based Randomized Control Trial
The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.
Read the detailed description
The prime objective of this study is to estimate the independent effect of 4% Chlorhexidine solution application to cord stump and hand washing with soap by mothers of newborns for 2 weeks after birth in reducing Omphalitis in neonates compared to routine cord care by TBAs (Traditional Birth Attendant) in rural district of Sindh, Pakistan.
This study will be conducted in existing health infrastructure in a community setting with the help of two principal health care providers, TBAs and CHWs Community Health Workers) involved in maternal and newborn care. The TBAs conducting delivery wil be trained to wash hands with soap and water after completion of delivery and apply chlorhexidine to the Umbilical Cord Stump. The procedure will be repeated by the mother on the subsequent days up til 14 days from birth. The CHWs will also be trained to recognized signs of Omphalitis and record Cord Care in a systemic manner in a structured proforma.
The study will continue longitudinally for a period of one year to follow newborn for the signs of Omphalitis.
- Conditions
- Omphalitis
- Being tested
- 4% Chlorhexidine, Hand washing Soap
- Keywords
- Omphalitis, 4% Chlorhexidine, Newborns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% ChlorhexidineDrug
4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.
Hand washing SoapOther
Hand washing soap was provided to Mothers through TBAs.
4% ChlorhexidineDrug
4% Chlorhexidine was provided to be applied by Mothers through TBAs.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | In this arm we recruited 2,400 subjects who received Intervention. Receives: Drug: 4% Chlorhexidine |
| B | Experimental | In this Arm, we recruited 2,400 subjects who received intervention. Receives: Other: Hand washing Soap |
| C | Experimental | In this Arm, we recruited 2,400 subjects who received intervention. Receives: Drug: 4% Chlorhexidine |
| D | No intervention | In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Neonatal Omphalitis
Measured: By the end of the styudy
Rate of Neonatal Mortality
Measured: By the end of the Study
Secondary outcomes (4)
Breastfeeding rate
Measured: By the end of the Study
Rate of Serious Neonatal Infections
Measured: By the end of the Study
Utilization of Clean Delivery Kits
Measured: By the end of the Study
Application Practice of Chlorhexidine
Measured: By the end of the Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OmphalitisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 9,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- John Snow, Inc.
- Investigators
- Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682006
- Sponsor's protocol ID
- 683-Ped/ERC-06
- Acronym
- Chlorhexidine
- Status last verified
- Jul 2009
- First submitted
- 19 May 2008
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8.
PubMed 22322126
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan: A Community-based Randomized Control Trial
- ClinicalTrials.gov ID
- NCT00682006
- Acronym / sponsor ID
- Chlorhexidine / 683-Ped/ERC-06
- Conditions
- Omphalitis
- Keywords
- Omphalitis, 4% Chlorhexidine, Newborns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,800 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- John Snow, Inc.
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 May 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.
The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.
Detailed description
The prime objective of this study is to estimate the independent effect of 4% Chlorhexidine solution application to cord stump and hand washing with soap by mothers of newborns for 2 weeks after birth in reducing Omphalitis in neonates compared to routine cord care by TBAs (Traditional Birth Attendant) in rural district of Sindh, Pakistan.
This study will be conducted in existing health infrastructure in a community setting with the help of two principal health care providers, TBAs and CHWs Community Health Workers) involved in maternal and newborn care. The TBAs conducting delivery wil be trained to wash hands with soap and water after completion of delivery and apply chlorhexidine to the Umbilical Cord Stump. The procedure will be repeated by the mother on the subsequent days up til 14 days from birth. The CHWs will also be trained to recognized signs of Omphalitis and record Cord Care in a systemic manner in a structured proforma.
The study will continue longitudinally for a period of one year to follow newborn for the signs of Omphalitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: 4% ChlorhexidineIn this arm we recruited 2,400 subjects who received Intervention. |
| B | Experimental | Other: Hand washing SoapIn this Arm, we recruited 2,400 subjects who received intervention. |
| C | Experimental | Drug: 4% ChlorhexidineIn this Arm, we recruited 2,400 subjects who received intervention. |
| D | No intervention | –In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All healthy newborns, born in the study setting will be systematically enrolled in the trial
Key exclusion criteria (2 listed)
- Infants with congenital/birth defects
- Infants with any localized infection on the peri-umbilical region at the time of birth or application of any other material such as dung, etc before enrollment on the Cord.
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 |
|---|---|---|
| 4% Chlorhexidine4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs. | Drug | A |
| Hand washing SoapHand washing soap was provided to Mothers through TBAs. | Other | B |
| 4% Chlorhexidine4% Chlorhexidine was provided to be applied by Mothers through TBAs. | Drug | C |
Primary outcome
Incidence of Neonatal Omphalitis
Time frame: By the end of the styudy
Rate of Neonatal Mortality
Time frame: By the end of the Study
4 secondary outcomes
Breastfeeding rate
Time frame: By the end of the Study
Rate of Serious Neonatal Infections
Time frame: By the end of the Study
Utilization of Clean Delivery Kits
Time frame: By the end of the Study
Application Practice of Chlorhexidine
Time frame: By the end of the Study
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 8 Jul 2011.
- Derived from this study: PubMed 22322126Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8.
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.
Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP 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 Phase 3 study testing 4% Chlorhexidine and Hand washing Soap in people with Omphalitis, 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 2 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 8 Jul 2011. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of Neonatal Omphalitis (time frame: By the end of the styudy). The study lists 2 primary outcomes in all. 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 NCT00682006, which also lists 1 linked publication.
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 8 Jul 2011.