NCT02802332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,574

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

June 13, 2016

Last Update Submit

April 19, 2018

Conditions

Keywords

neonatalpretermNepalfamily-initiated identificationbasic newborn care

Outcome Measures

Primary Outcomes (2)

  • skin to skin contact

    Does the mother report practicing skin to skin contact during the first 28 days after birth

    within 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

    within first 28 days after birth

Study Arms (2)

Footlength Card

ACTIVE COMPARATOR

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

No Footlength Card

NO INTERVENTION

Women in this group do receive any footlength card.

Interventions

Footlength CardBEHAVIORAL

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

Footlength Card

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nepal Nutrition Intervention Project

Hariaun, Sarlahi District, Nepal

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Luke C Mullany, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 16, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 23, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

There is currently no plan to share individual participant data

Locations