Study Results
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Basic Information
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COMPLETED
PHASE3
8518 participants
INTERVENTIONAL
2014-04-30
2017-02-26
Brief Summary
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Detailed Description
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In Pakistan, it is estimated that over 200,000 newborns die each year before they reach the end of their first month of life, representing nearly 58% of all deaths among children under the age of five. The risk of neonatal death in Pakistan is higher in rural areas than in urban areas; the neonatal mortality rate (NMR) in rural areas is 55 per 1,000 live births compared to 48 per 1,000 live births in urban areas. NMR in Pakistan is also associated with poverty; the NMR in highest wealth quintile is 38 compared to 63 per 1000 live births in lowest wealth quintile.
In resource poor settings, newborns are most often delivered at home and receive minimal specific medical care, measurement, or monitoring. In these areas, geography, infrastructure, and poverty often effectively prevent access to health centers and care. Home outreach with trained Community health workers (CHWs) is increasingly recognized as the mainstay for provision of maternal and newborn care in these settings. Many proven, cost-effective ways to save the lives of newborns exist, however, they are not always available to those who need them most nor have they been packaged into a single portable kit that can be easily used in the home-setting. Such a portable kit consisting of low cost, evidence-based interventions for use in the home has tremendous potential to improve health status and decrease NMR.
In this study, the investigators hypothesize that the implementation of an integrated evidence-based toolkit by CHWs will reduce neonatal deaths by at least 40% through a reduction in both infectious causes of death and those associated with prematurity and LBW. Furthermore, the investigators propose that there will be an additive effect from the mortality benefit of specific kit components. The portable kit will contain a clean birth kit to be used at the time of delivery either at home or in a facility, 4% chlorhexidine (CHX) lotion, sunflower oil emollient, ThermoSpot, a Mylar infant sleeve, and a reusable, non-electric, heating device. CHWs will be equipped with a hand held electric scale to identify LBW newborns.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Neonatal Kit
The neonatal kit will contain a clean birth kit to be used at the time of delivery either at home or in a facility, 4% chlorhexidine (CHX) lotion, sunflower oil emollient, ThermoSpot, a Mylar infant sleeve, and a reusable, non-electric, heating device. Lady Health Workers will be equipped with a hand held electric scale to identify low birth weight newborns.
Neonatal kit
Contents of the neonatal kit:
1. Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp.
2. 4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls.
3. Sunflower oil emollient (50 mL)
4. ThermoSpot
5. Mylar infant sleeve
6. Click to heat warmer (http://www.heatinaclick.ca/products/pocket\_size.html) in a fitted cloth pouch.
7. Handheld electric scale with suspended cloth sling. The scale will not be included with the kit but rather one will be issued to each Lady Health Worker.
Control (Standard care)
In the control arm, Lady Health Workers will visit the home according to the regular schedule (same as in the intervention clusters) and will deliver the standard post-natal care consisting of:
1. be present at delivery (though not conduct the delivery) and thorough examination of newborn and mother post delivery
2. check mother for vaginal bleeding and abnormal blood pressure and make referral to nearest health facility as appropriate
3. refer any newborn with congenital anomaly or evidence of asphyxia
4. if unable to attend delivery for any reason, visit within first 24 hours post delivery
5. assess newborn in first month of life during visits and provide basic treatment for acute respiratory infections, pneumonia, and diarrhea in the home
6. encourage breastfeeding
No interventions assigned to this group
Interventions
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Neonatal kit
Contents of the neonatal kit:
1. Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp.
2. 4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls.
3. Sunflower oil emollient (50 mL)
4. ThermoSpot
5. Mylar infant sleeve
6. Click to heat warmer (http://www.heatinaclick.ca/products/pocket\_size.html) in a fitted cloth pouch.
7. Handheld electric scale with suspended cloth sling. The scale will not be included with the kit but rather one will be issued to each Lady Health Worker.
Eligibility Criteria
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Inclusion Criteria
* Mother intending to maintain residence in study area for first month of newborn's life
Exclusion Criteria
FEMALE
No
Sponsors
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Grand Challenges Canada
OTHER
UBS Optimus Foundation
OTHER
Mother and Child Care Trust (MCCT), Pakistan
UNKNOWN
Aga Khan University
OTHER
March of Dimes
OTHER
The Hospital for Sick Children
OTHER
Responsible Party
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Shaun Morris
Associate Staff Physician
Principal Investigators
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Shaun K. Morris, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto
Zulfiqar A. Bhutta, PhD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University
Locations
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Aga Khan University
Karachi, , Pakistan
Countries
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References
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Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
Khan A, Kinney MV, Hazir T, Hafeez A, Wall SN, Ali N, Lawn JE, Badar A, Khan AA, Uzma Q, Bhutta ZA; Pakistan Newborn Change and Future Analysis Group. Newborn survival in Pakistan: a decade of change and future implications. Health Policy Plan. 2012 Jul;27 Suppl 3:iii72-87. doi: 10.1093/heapol/czs047.
Bhutta ZA, Rehman S. Perinatal care in Pakistan: a situational analysis. J Perinatol. 1997 Jan-Feb;17(1):54-9.
Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8. doi: 10.1016/S0140-6736(06)68381-5.
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.
Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.
Darmstadt GL, Saha SK, Ahmed AS, Ahmed S, Chowdhury MA, Law PA, Rosenberg RE, Black RE, Santosham M. Effect of skin barrier therapy on neonatal mortality rates in preterm infants in Bangladesh: a randomized, controlled, clinical trial. Pediatrics. 2008 Mar;121(3):522-9. doi: 10.1542/peds.2007-0213.
Green DA, Kumar A, Khanna R. Neonatal hypothermia detection by ThermoSpot in Indian urban slum dwellings. Arch Dis Child Fetal Neonatal Ed. 2006 Mar;91(2):F96-8. doi: 10.1136/adc.2005.078410. Epub 2005 Sep 13.
Krautheim AB, Jermann TH, Bircher AJ. Chlorhexidine anaphylaxis: case report and review of the literature. Contact Dermatitis. 2004 Mar;50(3):113-6. doi: 10.1111/j.0105-1873.2004.00308.x.
Rosenberg A, Alatary SD, Peterson AF. Safety and efficacy of the antiseptic chlorhexidine gluconate. Surg Gynecol Obstet. 1976 Nov;143(5):789-92.
Garland JS, Alex CP, Mueller CD, Otten D, Shivpuri C, Harris MC, Naples M, Pellegrini J, Buck RK, McAuliffe TL, Goldmann DA, Maki DG. A randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates. Pediatrics. 2001 Jun;107(6):1431-6. doi: 10.1542/peds.107.6.1431.
Darmstadt GL, Mao-Qiang M, Chi E, Saha SK, Ziboh VA, Black RE, Santosham M, Elias PM. Impact of topical oils on the skin barrier: possible implications for neonatal health in developing countries. Acta Paediatr. 2002;91(5):546-54. doi: 10.1080/080352502753711678.
Darmstadt GL, Saha SK, Ahmed AS, Chowdhury MA, Law PA, Ahmed S, Alam MA, Black RE, Santosham M. Effect of topical treatment with skin barrier-enhancing emollients on nosocomial infections in preterm infants in Bangladesh: a randomised controlled trial. Lancet. 2005 Mar 19-25;365(9464):1039-45. doi: 10.1016/S0140-6736(05)71140-5.
Lawn JE, Kinney MV, Black RE, Pitt C, Cousens S, Kerber K, Corbett E, Moran AC, Morrissey CS, Oestergaard MZ. Newborn survival: a multi-country analysis of a decade of change. Health Policy Plan. 2012 Jul;27 Suppl 3:iii6-28. doi: 10.1093/heapol/czs053.
Duby J, Pell LG, Ariff S, Khan A, Bhutta A, Farrar DS, Bassani DG, Hussain M, Bhutta ZA, Soofi S, Morris SK. Effect of an integrated neonatal care kit on cause-specific neonatal mortality in rural Pakistan. Glob Health Action. 2020 Dec 31;13(1):1802952. doi: 10.1080/16549716.2020.1802952.
Turab A, Pell LG, Bassani DG, Soofi S, Ariff S, Bhutta ZA, Morris SK. The community-based delivery of an innovative neonatal kit to save newborn lives in rural Pakistan: design of a cluster randomized trial. BMC Pregnancy Childbirth. 2014 Sep 8;14:315. doi: 10.1186/1471-2393-14-315.
Other Identifiers
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1000042963
Identifier Type: -
Identifier Source: org_study_id
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