Neonatal Mortality Clinical Trial
— iNCKOfficial title:
An Integrated Newborn Care Kit to Save Newborn Lives and Improve Health Outcomes in Gilgit-Baltistan, Pakistan
NCT number | NCT04798833 |
Other study ID # | TTS181021048 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 7, 2021 |
Est. completion date | June 2024 |
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.
Status | Recruiting |
Enrollment | 27448 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan Health Services, Pakistan | Islamabad | |
Pakistan | Aga Khan University | Karachi |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children | Aga Khan Health Services, Aga Khan University, The Aga Khan Foundation |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause neonatal mortality | Death from any cause within the first 28 days of life | Day 29 postnatal age | |
Secondary | 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 |
Day 29 postnatal age | |
Secondary | 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 |
Day 29 postnatal age | |
Secondary | Health facility utilization | Self-reported health facility utilization by pregnant women, and/or neonates and mothers in the first month post-partum | Day 29 postnatal age | |
Secondary | 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 | Day 29 postnatal age | |
Secondary | 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 | Day 29 postnatal age | |
Secondary | 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 | Day 29 postnatal age | |
Secondary | 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 | 29 postnatal age | |
Secondary | Cause-specific neonatal mortality | Death from specific causes within the first 28 days of life | Day 29 postnatal age |
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