Newborn Care Kit to Save Lives in GB, Pakistan

NCT04798833 | Active Not Recruiting DMC

• 1 other identifier: TTS181021048
• Study Type: interventional
• Target: 27,448
• Locations: 1 country
• Sites: 2

Brief Summary

Neonatal deaths account for almost half of all deaths in children under 5 years of age. Pakistan has the world's highest neonatal mortality rate (NMR), and many of these deaths are preventable. In this study, the investigators propose the use of an evidence-based, integrated newborn care kit (iNCK) to promote safer delivery, provide early identification of danger signs, improve newborn health, and reduce NMR. The investigators hypothesize that use of the iNCK will result in at least a 25% reduction in NMR among participants who receive the iNCK compared with participants who do not receive the iNCK.

Conditions

Neonatal Mortality; Omphalitis; Post-Partum Hemorrhage

Keywords

Neonatal Mortality; Neonatal kit; Pakistan; Randomized Control Trial; Chlorhexidine; Omphalitis; Newborn; Birth; Post-Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• All-cause neonatal mortality

  Death from any cause within the first 28 days of life

  Day 29 postnatal age

Secondary Outcomes (8)

• Cumulative incidence of omphalitis

  Day 29 postnatal age

• Cumulative incidence of post-partum hemorrhage (PPH)

  Day 29 postnatal age

• Health facility utilization

  Day 29 postnatal age

• Cumulative incidence of hypothermia among participants in the experimental arm

  Day 29 postnatal age

• Cumulative incidence of fever among participants in the experimental arm

  Day 29 postnatal age

Study Arms (2)

Integrated Newborn Care Kit

EXPERIMENTAL

The integrated newborn care kit will contain a clean birth kit to be used at the time of delivery either at home or in a facility, three misoprostol tablets (200ug each), 4% chlorhexidine solution, sunflower oil emollient, temperature monitoring strip or sticker, a fleece blanket, a reusable, non-electric, heating device, and a pictorial instruction guide. Lady Health Workers will be equipped with a hand-held electronic scale to identify low birth weight newborns. Participants in this arm will receive the same local standard of care as the no intervention arm.

Device: Integrated Newborn Care Kit (iNCK)

Control (Local Standard of Care)

NO INTERVENTION

In the control arm, LHWs will deliver the local standard of care, which entails both anti-natal and post-natal LHW home visits. As part of standard practice, LHWs visit pregnant women in their homes during the 3rd trimester, at which time these health workers: * Provide instructions regarding proper nutrition during pregnancy * Encourage that delivery take place in a facility * Discuss the fundamentals of safe water, sanitation, and hygiene behavior * Encourage exclusive breastfeeding These community health workers will identify early danger signs in newborns such as infections and teach caregivers to identify the same symptoms, so that early interventions can be made. If danger signs are identified, the LHW will refer newborns to the appropriate level of health care.

Interventions

Integrated Newborn Care Kit (iNCK) DEVICE

Contents of the integrated newborn care kit: * Clean birth kit: sterile blade, clean plastic sheet, plastic gloves, hand soap, cord ties/clamp, maternity pad to absorb post-natal bleeding, 10 cotton balls for applying Chlorhexidine (CHX) to the umbilical stump. * 3x200 µg dissolvable tablets of misoprostol to be ingested prophylactically following delivery of the baby and before delivery of the placenta to prevent post-partum hemorrhage * 4% CHX solution (15 mL) * Sunflower oil emollient (50 mL) * Temperature monitoring strip or sticker * Fleece blanket for the newborn * Click to heat warmer * Pictorial guide that illustrates how and when to use each kit component * Handheld electronic 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 in the experimental arm) Other Names: Neonatal Care Kit

Also known as: Neonatal Care Kit

Integrated Newborn Care Kit

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Resides in a village with LHW coverage in participating union councils (clusters) in Astore, Diamer, Shigar, Ghanche, Kharmang, and Skardu, districts of GB, Pakistan
• In their 3rd trimester of pregnancy (≥ week 27 gestational age)
• Intends to be present in the study catchment area between day 29 and 35 postnatal age
• Provides written informed consent or assent
• Starting in approximately month 26 of the study, only women ≥36 weeks of gestational age will be enrolled.

You may not qualify if:

• Does not reside within the study's catchment area at the time of enrolment
• Plans to relocate outside of the study catchment area within one month after the delivery of their newborn(s) and not return to the study catchment area
• Does not provide written informed consent or assent
• Lives in a village without LHW coverage

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Aga Khan Foundation: collaborator
• Aga Khan Health Services: collaborator
• Aga Khan University: collaborator

Study Sites (2)

Aga Khan Health Services, Pakistan

Islamabad, Pakistan

Location

Aga Khan University

Karachi, Pakistan

Location

Related Publications (1)

• Fadaleh SMA, Pell LG, Yasin M, Farrar DS, Khan SH, Tanner Z, Paracha S, Madhani F, Bassani DG, Ahmed I, Soofi SB, Taljaard M, Spitzer RF, Bhutta ZA, Morris SK. An integrated newborn care kit (iNCK) to save newborn lives and improve health outcomes in Gilgit Baltistan (GB), Pakistan: study protocol for a cluster randomized controlled trial. BMC Public Health. 2023 Dec 11;23(1):2480. doi: 10.1186/s12889-023-17322-y.

  PMID: 38082395 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shaun Morris, MD, MPH

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 15, 2021
• Study Start: June 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)