Newborn Care Kit to Save Lives in GB, Pakistan

NCT ID: NCT04798833

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 27448 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

While some progress has been made towards reducing global under-5 mortality, in 2019, an estimated 2.4 million newborn deaths still occurred worldwide, accounting for 47% of all under-five deaths. Most neonatal deaths are caused by prematurity, sepsis, and intrapartum-related complications.

Pakistan has the highest neonatal mortality rate (NMR) in the world, at 42 deaths per 1,000 live births. Gilgit-Baltistan (GB), Pakistan's remote, northern-most administrative territory, is afflicted with some of the country's worst NMRs. High rates of home deliveries, low adoption of safe birth practices, inadequate cord care, and high maternal mortality contribute to this health disparity. GB's geography, climate, and underdeveloped infrastructure also largely restrict access to health care facilities. Health care at the community level in Pakistan is primarily supported by the Lady Health Worker (LHW) Programme. LHWs form a cadre of government-supported community health workers who provide newborn and maternal health services in GB. However, each of these health care workers is responsible for approximately 1,000 people, which restricts both availability and comprehensiveness of care, particularly for families that live in hard to reach areas.

Many proven, cost-effective ways to save newborn lives and improve wellbeing exist; however, they are not always available to those who need them most, nor are they packaged into a single portable kit that can be used in the home. An easy-to-use kit consisting of low cost, evidence-based interventions has potential to improve health status, reduce NMR, and provide more timely access to health services in remote areas such as GB. Between April 2014 and August 2015, the investigators conducted a community-based, cluster randomized intervention trial examining the effectiveness of delivering an integrated newborn care kit (iNCK) to pregnant women in Rahim Yar Khan (RYK), Punjab, Pakistan. The iNCKs were delivered by LHWs, who also educated participants how to use the different kit components. Neonatal mortality and morbidity outcomes were compared between iNCK recipients and a local control group who received the same standard of care, but no iNCK. The investigators found that while distribution of the iNCK did not significantly reduce neonatal mortality, utilization of the iNCK significantly reduced the risk of omphalitis and fever. Moreover, using the LHW network to distribute the intervention proved a feasible delivery mechanism.

The findings from the RYK trial suggest that while a network of community health workers can reliably deliver integrated interventions to pregnant women, further investigation is needed to improve the integration of educational content and maximize the iNCK's potential health benefits. Moreover, effective delivery of maternal health interventions through the iNCK warrants examination, as Pakistan experiences some of the world's highest rates of maternal mortality, of which post-partum hemorrhage (PPH) is a leading cause.

Conditions

Neonatal Mortality; Omphalitis; Post-Partum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Integrated Newborn Care Kit

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.

Group Type: EXPERIMENTAL

Integrated Newborn Care Kit (iNCK)

Intervention Type: 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

Control (Local Standard of Care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrated Newborn Care Kit (iNCK)

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

Intervention Type: DEVICE

Other Intervention Names

Neonatal Care Kit

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Aga Khan Foundation

OTHER

Sponsor Role: collaborator

Aga Khan Health Services

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Shaun Morris

Clinician-Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaun Morris, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Aga Khan Health Services, Pakistan

Islamabad, , Pakistan

Aga Khan University

Karachi, , Pakistan

Countries

Pakistan

References

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.

Reference Type: DERIVED

PMID: 38082395 (View on PubMed)

Other Identifiers

TTS181021048

Identifier Type: -

Identifier Source: org_study_id