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Newborn Kit to Save Lives in Pakistan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02130856
Recruitment Status : Completed
First Posted : May 5, 2014
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
Grand Challenges Canada
UBS Optimus Foundation
Mother and Child Care Trust (MCCT), Pakistan
Aga Khan University
March of Dimes
Information provided by (Responsible Party):
Shaun Morris, The Hospital for Sick Children

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neonatal Mortality Device: Neonatal kit Phase 3

Detailed Description:

Over 3 million global neonatal deaths are reported annually. While significant progress has been made over the past decade towards reducing overall under 5 mortality, very little progress has been made towards the reduction of neonatal deaths, which represent about 40% of all deaths in children under the age of 5. The majority of neonatal deaths occur in rural areas of low-income countries and approximately two thirds are due to infection and complications relating to low birth weight (LBW) and prematurity.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Integrated Toolkit to Save Newborn Lives in Pakistan
Study Start Date : April 2014
Actual Primary Completion Date : February 26, 2017
Actual Study Completion Date : February 26, 2017

Arm Intervention/treatment
Experimental: 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.
Device: 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.

No Intervention: 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



Primary Outcome Measures :
  1. Neonatal mortality [ Time Frame: 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. ]
    Death from any cause within the first 28 days of life


Secondary Outcome Measures :
  1. Incidence of omphalitis [ Time Frame: 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. ]

    Incidence of omphalitis where omphalitis is defined as:

    1. None (no redness or swelling)
    2. Mild (inflammation limited to the cord stump)
    3. Moderate (inflammation extending less than 2cm to the skin at the base of the cord stump)
    4. Severe (inflammation extending more than 2cm from the cord stump)

  2. Incidence of severe infection [ Time Frame: 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. ]

    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.


  3. Cases of hypothermia identified [ Time Frame: 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. ]

    Hypothermia defined using ThermoSpot as:

    1. Moderate hypothermia: pale green and red face (35C to 36C)
    2. Severe hypothermia: black face (<35C)

  4. Cases of hyperthermia identified [ Time Frame: 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. ]

    Hyperthermia defined using ThermoSpot as:

    a) Hyperthermia: blue face (>39C)


  5. Number of low birth weight (LBW) newborns identified [ Time Frame: 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. ]

    LBW is defined as:

    <2500 grams at first weighing


  6. Health Facility Use [ Time Frame: 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. ]
  7. Neurodevelopmental score at 12 months of age [ Time Frame: Month 12 of life (only during phase I of the study) ]
    Assessed by the Bayley Scale of Infant Development III (BSID III).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130856


Locations
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Pakistan
Aga Khan University
Karachi, Pakistan, 74800
Sponsors and Collaborators
The Hospital for Sick Children
Grand Challenges Canada
UBS Optimus Foundation
Mother and Child Care Trust (MCCT), Pakistan
Aga Khan University
March of Dimes
Investigators
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Principal Investigator: Shaun K. Morris, MD, MPH The Hospital for Sick Children, Toronto
Principal Investigator: Zulfiqar A. Bhutta, PhD, MBBS Aga Khan University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shaun Morris, Associate Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02130856    
Other Study ID Numbers: 1000042963
First Posted: May 5, 2014    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Shaun Morris, The Hospital for Sick Children:
Neonatal mortality
Neonatal kit
Pakistan
Randomized Control Trial
Chlorhexidine
ThermoSpot
Birth
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents