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Trial record 28 of 107 for:    ( Map: Nepal )

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

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ClinicalTrials.gov Identifier: NCT02802332
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
Save the Children
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
Low Birth Weight Babies Preterm Babies Behavioral: Footlength Card Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4574 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of a Foot Length Card to Improve Careseeking Practices of Vulnerable Newborns in Sarlahi District, Nepal
Actual Study Start Date : July 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Footlength Card
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
Behavioral: Footlength Card
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

No Intervention: No Footlength Card
Women in this group do receive any footlength card.



Primary Outcome Measures :
  1. skin to skin contact [ Time Frame: within first 28 days after birth ]
    Does the mother report practicing skin to skin contact during the first 28 days after birth

  2. careseeking for newborn [ Time Frame: within first 28 days after birth ]
    Does the mother report seeking care for newborn (either routine postnatal care OR careseeking for illness) during the first 28 days after birth



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802332


Locations
Nepal
Nepal Nutrition Intervention Project
Hariaun, Sarlahi District, Nepal
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Save the Children
Investigators
Principal Investigator: Luke C Mullany, PhD Johns Hopkins University

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02802332     History of Changes
Other Study ID Numbers: 00085037
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share individual participant data

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
neonatal
preterm
Nepal
family-initiated identification
basic newborn care

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms