Clinical trial NCT02802332: Use of a Foot Length Card to Improve Careseeking Practices of Vulnerable Newborns in Sarlahi District, Nepal
Official title: Use of a Foot Length Card to Improve Careseeking Practices of Vulnerable Newborns in Sarlahi District, Nepal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Birth Weight Babies
Preterm Babies
Keywords: neonatal
preterm
Nepal
family-initiated identification
basic newborn care
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Save the Children
First posted: 2016-06-16
Enrollment: 4574
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will evaluate whether or not provision of a simple card ("footlength card") that allows identification of low birth weight and/or preterm babies through measurement of the length of a baby's foot, can improve basic newborn care behaviors in rural Nepal.

Detailed description: This study will evaluate a recently developed, simple, low-cost tool that can help recently delivered women and their family members identify whether or not their newborn baby needs extra care/attention. Some prior studies of the relationship between anthropometric measures (such as chest-circumference, footlength, head circumference, etc) and preterm birth or low birth weight, have shown that these measures can be used to identify high-risk/vulnerable babies. One such measure, foot length, has been shown to be a reasonable tool, and one that can be simply performed by mothers, without disturbing the newborn infant. With this in mind, Save The Children has developed a low cost card with an image of a baby's foot on one side, along with a toll-free number and some key messages on how to use the card. Specifically, pregnant women can be given this card during an antenatal contact, along with some basic instructions on its use. Then, after their baby is born, the newly delivered woman, other family member, or low-level facility provider can compare the length of the baby's foot to the image on the card, by lining the baby's foot up with the card. If the baby's foot is shorter than the image on the card, a toll-free number (provided on the card itself) can be used to access a set of standardized messages about how to take care of the baby.

In this proposed study, Save the Children, Johns Hopkins University (JHU), and the JHU-led Nepal Nutrition Intervention Project - Sarlahi (NNIPS) will give this card to women currently enrolled in the Nepal Oil Massage Study (NCT01177111), explain its use, follow up with the woman after delivery to determine if she used the card, and query her about her experience using the card, calling the toll-free number, and recalling the messages given. Additionally, one of the NNIPS staff workers will use the same card to measure the baby's foot. Ultimately, the study will summarize women's experience using this card, and provide guidance to Save the Children, the Ministry of Health and Population (MOHP), and other stakeholders regarding future programmatic scale up of the use of this card.

Eligibility criteria: Inclusion Criteria:

* Woman is pregnant
* Woman is enrolled in ongoing newborn oil massage study

Exclusion Criteria:

* Not pregnant
* Not enrolled in ongoing newborn oil massage study

Primary outcomes:
measure: skin to skin contact
timeFrame: within first 28 days after birth
measure: careseeking for newborn
timeFrame: within first 28 days after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Hariaun
country: Nepal
facility: Nepal Nutrition Intervention Project
state: Sarlahi District
Study officials:
affiliation: Johns Hopkins University
name: Luke C Mullany, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hodgins S, Rajbhandari B, Joshi D, Ban B, Khatry S, Mullany LC. Community-based cluster randomized controlled trial: empowering households to identify and provide appropriate care for low-birthweight newborns in Nepal. BMC Public Health. 2020 Aug 24;20(1):1274. doi: 10.1186/s12889-020-09317-w.