Neonatal MortalityiNCKNCT04798833
Newborn Care Kit to Save Lives in GB, Pakistan
A study testing Integrated Newborn Care Kit (iNCK) in people with Neonatal Mortality and Omphalitis, run by The Hospital for Sick Children at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neonatal Mortality, Omphalitis, Post-Partum Hemorrhage
- What is being tested?
- Integrated Newborn Care Kit (iNCK)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,344 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Mar 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Aga Khan Health Services, Pakistan
Islamabad
Aga Khan University
Karachi
About this study
Official title: An Integrated Newborn Care Kit to Save Newborn Lives and Improve Health Outcomes in Gilgit-Baltistan, Pakistan
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.
Read the 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
- Being tested
- Integrated Newborn Care Kit (iNCK)
- Keywords
- Neonatal Mortality, Neonatal kit, Pakistan, Randomized Control Trial, Chlorhexidine, Omphalitis, Newborn, Birth, Post-Partum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Newborn Care Kit (iNCK)Device
Also called Neonatal Care Kit
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause neonatal mortality
Death from any cause within the first 28 days of life
Measured: Day 29 postnatal age
Secondary outcomes (8)
Cumulative incidence of omphalitis
Cumulative incidence of omphalitis among neonates where omphalitis is defined as:
- redness around the base of the baby's umbilical stump or surrounding skin OR
- the presence of pus on or near the baby's umbilical stump
Measured: Day 29 postnatal age
Cumulative incidence of post-partum hemorrhage (PPH)
Cumulative incidence of PPH is self-reported. PPH is defined as having experienced any of the following:
- Post-delivery vaginal bleeding that pooled on the mattress/floor where the delivery took place
- Having sought health care for post-delivery vaginal bleeding
- Having received a blood transfusion after delivery
- Having been diagnosed with PPH
- Vaginal bleeding being reported as the cause of the mother's death
Measured: Day 29 postnatal age
Health facility utilization
Self-reported health facility utilization by pregnant women, and/or neonates and mothers in the first month post-partum
Measured: Day 29 postnatal age
Cumulative incidence of hypothermia among participants in the experimental arm
Cumulative incidence of hypothermia defined by color change in temperature monitoring strip or sticker that indicates lower than normal temperature
Measured: Day 29 postnatal age
Cumulative incidence of fever among participants in the experimental arm
Cumulative incidence of fever defined by color change in temperature monitoring strip or sticker that indicates higher than normal temperature
Measured: Day 29 postnatal age
Correlates of iNCK instructional compliance
Correlates of iNCK instructional compliance, using a process analysis to explore the correlation between compliance and maternal, infant, sociodemographic characteristics, and Lady Health Worker teaching quality
Measured: Day 29 postnatal age
Correlates of willingness to pay for the iNCK
Explore the correlation between maternal, infant, and sociodemographic characteristics, and knowledge, attitudes, practice, and willingness to pay for the iNCK
Measured: 29 postnatal age
Cause-specific neonatal mortality
Death from specific causes within the first 28 days of life
Measured: Day 29 postnatal age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Mar 2022
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal MortalityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Aga Khan Foundation, Aga Khan Health Services, Aga Khan University
- Responsible party
- Principal investigator, Shaun Morris, The Hospital for Sick Children
- Investigators
- Shaun Morris, MD, MPH, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798833
- Sponsor's protocol ID
- TTS181021048
- Acronym
- iNCK
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2021
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38082395
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Newborn Care Kit to Save Newborn Lives and Improve Health Outcomes in Gilgit-Baltistan, Pakistan
- ClinicalTrials.gov ID
- NCT04798833
- Acronym / sponsor ID
- iNCK / TTS181021048
- Conditions
- Neonatal Mortality, Omphalitis, Post-Partum Hemorrhage
- Keywords
- Neonatal Mortality, Neonatal kit, Pakistan, Randomized Control Trial, Chlorhexidine, Omphalitis, Newborn, Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,344 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Aga Khan Foundation, Aga Khan Health Services, Aga Khan University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Newborn Care Kit | Experimental | Device: Integrated Newborn Care Kit (iNCK)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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Newborn Care Kit (iNCK)Also: Neonatal Care KitContents 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 | Device | Integrated Newborn Care Kit |
Primary outcome
All-cause neonatal mortality
Time frame: Day 29 postnatal age
Death from any cause within the first 28 days of life
8 secondary outcomes
Cumulative incidence of omphalitis
Time frame: Day 29 postnatal age
Cumulative incidence of post-partum hemorrhage (PPH)
Time frame: Day 29 postnatal age
Health facility utilization
Time frame: Day 29 postnatal age
Cumulative incidence of hypothermia among participants in the experimental arm
Time frame: Day 29 postnatal age
Cumulative incidence of fever among participants in the experimental arm
Time frame: Day 29 postnatal age
Correlates of iNCK instructional compliance
Time frame: Day 29 postnatal age
Correlates of willingness to pay for the iNCK
Time frame: 29 postnatal age
Cause-specific neonatal mortality
Time frame: Day 29 postnatal age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 38082395Fadaleh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaun Morris, MD, MPH principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Newborn Care Kit (iNCK) in people with Neonatal Mortality and Omphalitis, run by The Hospital for Sick Children at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause neonatal mortality (time frame: Day 29 postnatal age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.