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Use of a Foot Length Card to Improve Careseeking Practices of Vulnerable Newborns in Sarlahi District, Nepal

Primary Purpose

Low Birth Weight Babies, Preterm Babies

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Footlength Card
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Birth Weight Babies focused on measuring neonatal, preterm, Nepal, family-initiated identification, basic newborn care

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Nepal Nutrition Intervention Project

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Footlength Card

No Footlength Card

Arm Description

Pregnant women will receive a card that enables them to measure the length of their baby's foot. The card contains a phone number to pre-recorded message that provides basic information/advice regarding care of preterm and/or low birth weight babies

Women in this group do receive any footlength card.

Outcomes

Primary Outcome Measures

skin to skin contact
Does the mother report practicing skin to skin contact during the first 28 days after birth
careseeking for newborn
Does the mother report seeking care for newborn (either routine postnatal care OR careseeking for illness) during the first 28 days after birth

Secondary Outcome Measures

Full Information

First Posted
June 13, 2016
Last Updated
April 19, 2018
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Save the Children
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1. Study Identification

Unique Protocol Identification Number
NCT02802332
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Save the Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight Babies, Preterm Babies
Keywords
neonatal, preterm, Nepal, family-initiated identification, basic newborn care

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4574 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Footlength Card
Arm Type
Active Comparator
Arm Description
Pregnant women will receive a card that enables them to measure the length of their baby's foot. The card contains a phone number to pre-recorded message that provides basic information/advice regarding care of preterm and/or low birth weight babies
Arm Title
No Footlength Card
Arm Type
No Intervention
Arm Description
Women in this group do receive any footlength card.
Intervention Type
Behavioral
Intervention Name(s)
Footlength Card
Intervention Description
The footlength card has an image of a baby's foot. The card is to be held up against the baby's foot after birth; if a baby's foot is smaller than the image, or if the woman/family member is concerned about the health of their baby, they can call the number printed on the card and hear a pre-recorded message about basic care for newborn babies
Primary Outcome Measure Information:
Title
skin to skin contact
Description
Does the mother report practicing skin to skin contact during the first 28 days after birth
Time Frame
within first 28 days after birth
Title
careseeking for newborn
Description
Does the mother report seeking care for newborn (either routine postnatal care OR careseeking for illness) during the first 28 days after birth
Time Frame
within first 28 days after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luke C Mullany, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nepal Nutrition Intervention Project
City
Hariaun
State/Province
Sarlahi District
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plan to share individual participant data
Citations:
PubMed Identifier
32838783
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.
Results Reference
derived

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Use of a Foot Length Card to Improve Careseeking Practices of Vulnerable Newborns in Sarlahi District, Nepal

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