Neonatal InfectionsPhase 4NCT02279381
Neonatal Package Study in Rural District of Pakistan
A Phase 4 study testing Chlorhexidine, Kangaroo Mother Care and Essential Neonatal Care in people with Neonatal Infections, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Infections
- What is being tested?
- Chlorhexidine, Kangaroo Mother Care and Essential Neonatal Care
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,450 participants
- Where
- 1 sitePakistan
- Study dates
- Nov 2014to Nov 2015
- 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 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent.
Who cannot join
- Infants with congenital/birth defects,
- 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: A Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Efficacy of the Use of a Neonatal Package to Reduce Neonatal Infection in a Rural District of Pakistan
Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and essential neonatal care alone. The investigators anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.
Read the detailed description
The global neonatal mortality burden is one of the imminent factors which derail the achievement of the MDG 4 in many developing countries including Pakistan. Four million infants infants die in their first 28 days of their lives which account for about 40% of the total under-five mortality. The burden of neonatal mortality in Pakistan is alarming as the current neonatal mortality rate (NMR) is 55 per 1000 live births, third worst in the world. The major causes of these deaths are infections, preterm births and birth asphyxia which are avoidable. Despite many initiatives the NMR remains unchanged since last decade in Pakistan.
Literature shows that low cost facility and community based interventions can reduce NMR significantly. Early neonatal care, application of chlorhexidine for cord care and Kangaroo Mother Care (KMC) have been recognized as effective intervention in reduction of neonatal morbidity and subsequently neonatal mortality in many developing countries. However these interventions have never been tested as a package and data about their combined effect is scarce both in Pakistan and developing countries.
Considering the importance of the issue and well recognized interventions we are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, KMC and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and standard neonatal care alone. We anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.
- Conditions
- Neonatal Infections
- Being tested
- Chlorhexidine, Kangaroo Mother Care, Essential Neonatal Care
- Keywords
- Chlorhexidine, Kangaroo mother care, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called Antiseptic
4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10
Kangaroo Mother CareOther
Skin to Skin Care which is Kangaroo mother care will be carried out by mother from Day 1 till the study completion
Essential Neonatal CareOther
Essential Neonatal Care ensures delayed bathing, use of colostrum, exclusive breast feeding, skin to skin care for hypothermia, dry cord care, eye care and immunization for the newborn
| Study group | Role | What they receive |
|---|---|---|
| Intervention group A | Experimental | 1. Essential Neonatal Care
2. Kangaroo mother Care
3. Application of 4% Chlorhexidine
4. Education and counseling for mothers and care providers Receives: Drug: Chlorhexidine; Other: Kangaroo Mother Care; Other: Essential Neonatal Care |
| Intervention group B | Experimental | 1. Essential Neonatal Care
2. Application of 4% Chlorhexidine
3. Education and counseling for mothers and care providers Receives: Drug: Chlorhexidine; Other: Essential Neonatal Care |
| Control group | Active comparator | 1. Essential Neonatal Care
2. Education and counseling for mothers and care providers Receives: Other: Essential Neonatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)
Clinical presence of danger signs as per the IMNCI guidelines.
Measured: 28 days post recruitment
Secondary outcomes (3)
Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))
Redness and Swelling of umbilical stump/cord (Inflammation):
Measured: 28 days post recruitment
Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)
Weight, length and OFC appropriate for age as per WHO guidelines
Measured: 28 days post recruitment
Utilization of KMC Compliance, Frequency and duration
Compliance, Frequency and duration - hours/day
Measured: 28 days post recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, The International Federation of Red Cross and Red Crescent Societies
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Muhammad Atif Habib, MPH, Study director, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279381
- Sponsor's protocol ID
- 3106-Ped-ERC-14
- Status last verified
- Jun 2016
- First submitted
- 28 Oct 2014
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Acceptability, Feasibility and Efficacy of the Use of a Neonatal Package to Reduce Neonatal Infection in a Rural District of Pakistan
- ClinicalTrials.gov ID
- NCT02279381
- Acronym / sponsor ID
- 3106-Ped-ERC-14
- Conditions
- Neonatal Infections
- Keywords
- Chlorhexidine, Kangaroo mother care, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University of Sydney, The International Federation of Red Cross and Red Crescent Societies
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 Oct 2014 (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.
Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and essential neonatal care alone. The investigators anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.
Detailed description
The global neonatal mortality burden is one of the imminent factors which derail the achievement of the MDG 4 in many developing countries including Pakistan. Four million infants infants die in their first 28 days of their lives which account for about 40% of the total under-five mortality. The burden of neonatal mortality in Pakistan is alarming as the current neonatal mortality rate (NMR) is 55 per 1000 live births, third worst in the world. The major causes of these deaths are infections, preterm births and birth asphyxia which are avoidable. Despite many initiatives the NMR remains unchanged since last decade in Pakistan.
Literature shows that low cost facility and community based interventions can reduce NMR significantly. Early neonatal care, application of chlorhexidine for cord care and Kangaroo Mother Care (KMC) have been recognized as effective intervention in reduction of neonatal morbidity and subsequently neonatal mortality in many developing countries. However these interventions have never been tested as a package and data about their combined effect is scarce both in Pakistan and developing countries.
Considering the importance of the issue and well recognized interventions we are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, KMC and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and standard neonatal care alone. We anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group A | Experimental | Drug: Chlorhexidine, Other: Kangaroo Mother Care, Other: Essential Neonatal Care1. Essential Neonatal Care 2. Kangaroo mother Care 3. Application of 4% Chlorhexidine 4. Education and counseling for mothers and care providers |
| Intervention group B | Experimental | Drug: Chlorhexidine, Other: Essential Neonatal Care1. Essential Neonatal Care 2. Application of 4% Chlorhexidine 3. Education and counseling for mothers and care providers |
| Control group | Active comparator | Other: Essential Neonatal Care1. Essential Neonatal Care 2. Education and counseling for mothers and care providers |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent.
Key exclusion criteria (3 listed)
- Infants with congenital/birth defects,
- 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 |
|---|---|---|
| ChlorhexidineAlso: Antiseptic4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10 | Drug | Intervention group A, Intervention group B |
| Kangaroo Mother CareSkin to Skin Care which is Kangaroo mother care will be carried out by mother from Day 1 till the study completion | Other | Intervention group A |
| Essential Neonatal CareEssential Neonatal Care ensures delayed bathing, use of colostrum, exclusive breast feeding, skin to skin care for hypothermia, dry cord care, eye care and immunization for the newborn | Other | Control group, Intervention group A, Intervention group B |
Primary outcome
Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.)
Time frame: 28 days post recruitment
Clinical presence of danger signs as per the IMNCI guidelines.
3 secondary outcomes
Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation))
Time frame: 28 days post recruitment
Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines)
Time frame: 28 days post recruitment
Utilization of KMC Compliance, Frequency and duration
Time frame: 28 days post recruitment
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 9 Jun 2016.
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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.
Muhammad Atif Habib, MPH study director
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 4 study testing Chlorhexidine, Kangaroo Mother Care and Essential Neonatal Care in people with Neonatal Infections, 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 3 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 9 Jun 2016. 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 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?
Reduction in the Incidence of Neonatal infections in the first 28 days of life (Clinical presence of danger signs as per the IMNCI guidelines.) (time frame: 28 days post recruitment). 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 9 Jun 2016.