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| Name | Class |
|---|---|
| University of Sydney | OTHER |
| The International Federation of Red Cross and Red Crescent Societies | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group A | Experimental |
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| Intervention group B | Experimental |
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| Control group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | 4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days post recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the Incidence of omphalitis (Redness and Swelling of umbilical stump/cord (Inflammation)) | Redness and Swelling of umbilical stump/cord (Inflammation): | 28 days post recruitment |
| Failure to thrive (Weight, length and OFC appropriate for age as per WHO guidelines) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Atif Habib, MPH | Aga Khan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taluka Hospital KN Shah | Dadu | Sindh | Pakistan |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D000891 | Anti-Infective Agents, Local |
| D060127 | Kangaroo-Mother Care Method |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000890 |
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| Kangaroo Mother Care | Other | Skin to Skin Care which is Kangaroo mother care will be carried out by mother from Day 1 till the study completion |
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| Essential Neonatal Care | Other | 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 |
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Weight, length and OFC appropriate for age as per WHO guidelines |
| 28 days post recruitment |
| Utilization of KMC Compliance, Frequency and duration | Compliance, Frequency and duration - hours/day | 28 days post recruitment |
| Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D056888 | Patient Positioning |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D007224 | Infant Care |
| D002654 | Child Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |