Neonatal Mortality Clinical Trial
Official title:
An Integrated Toolkit to Save Newborn Lives in Pakistan
Verified date | April 2017 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There are over 3 million annual neonatal deaths. Approximately 2/3 of neonatal deaths are due to infection, low birth weight (LBW), and prematurity. Low tech but high impact interventions and commodities used in unconventional ways could save hundreds of thousands of newborn lives. We propose an integrated evidence-based toolkit usable by community health workers (CHW) to reduce neonatal deaths. The kit will include: Chlorhexidine to be applied to the umbilical stump, sunflower oil emollient to be applied to the skin, ThermoSpot to identify hypo/hyperthermia, and a Mylar infant sleeve with non-electric warmer.
Status | Completed |
Enrollment | 8518 |
Est. completion date | February 26, 2017 |
Est. primary completion date | February 26, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All pregnant women in parts of study clusters covered by Lady Health Worker program and their home- or facility-born live newborns - Mother intending to maintain residence in study area for first month of newborn's life Exclusion Criteria: - Failure to provide consent to enroll in study (intervention or control clusters) |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan University | Karachi |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Aga Khan University, Grand Challenges Canada, March of Dimes, Mother and Child Care Trust (MCCT), Pakistan, UBS Optimus Foundation |
Pakistan,
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. — View Citation
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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. — View Citation
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. — View Citation
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Krautheim AB, Jermann TH, Bircher AJ. Chlorhexidine anaphylaxis: case report and review of the literature. Contact Dermatitis. 2004 Mar;50(3):113-6. Review. — View Citation
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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. Erratum in: Lancet. 2012 Oct 13;380(9850):1308. — View Citation
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. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neonatal mortality | Death from any cause within the first 28 days of life | During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life. | |
Secondary | Incidence of omphalitis | Incidence of omphalitis where omphalitis is defined as: None (no redness or swelling) Mild (inflammation limited to the cord stump) Moderate (inflammation extending less than 2cm to the skin at the base of the cord stump) Severe (inflammation extending more than 2cm from the cord stump) |
During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life. | |
Secondary | Incidence of severe infection | Incidence of severe infection is defined as: a) Convulsions OR fast breathing (60 breaths per minute or more) OR severe chest indrawing OR movement only when stimulated or no movement at all OR not feeding at all for at least 12 hours. |
During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life. | |
Secondary | Cases of hypothermia identified | Hypothermia defined using ThermoSpot as: Moderate hypothermia: pale green and red face (35C to 36C) Severe hypothermia: black face (<35C) |
During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life. | |
Secondary | Cases of hyperthermia identified | Hyperthermia defined using ThermoSpot as: a) Hyperthermia: blue face (>39C) |
During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life. | |
Secondary | Number of low birth weight (LBW) newborns identified | LBW is defined as: <2500 grams at first weighing |
During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life. | |
Secondary | Health Facility Use | During phase I of the study: Day 1 (or as soon as possible after notification of birth), 3, 7, 14, and 28 of life. During phase II of the study: Day 8 and day 28 of life. | ||
Secondary | Neurodevelopmental score at 12 months of age | Assessed by the Bayley Scale of Infant Development III (BSID III). | Month 12 of life (only during phase I of the study) |
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