NCT06073444

Brief Summary

Neonatal jaundice (NNJ) is a common condition in newborns during the first week of life due to increased levels of bilirubin. Usually, it resolves without consequences after 7 to 10 days. However, around 10% of the newborns develop a severe form, which if is not detected on time, can lead to irreversible consequences including brain damage, disabilities and even death. The goal of this study is to determine the feasibility of implementing a smartphone app (Picterus JP) to screen for NNJ in low resource health facilities in Mexico and to evaluate its potential effectiveness to detect severe cases of the condition compared to the current used method that consists in visual assessment (VA). Research questions are:

  1. 1.Is it feasible to implement the smartphone app Picterus JP to screen for NNJ in low resource health facilities in Mexico?
  2. 2.Will Picterus JP increase the detection of severe NNJ compared to VA?
  3. 3.Newborns who attend the health facilities for neonatal check up
  4. 4.Health care workers (HCWs) using the app
  5. 5.Parents of newborns screened with Picterus JP
  6. 6.control group in which jaundice will be screened by healthcare workers using VA or
  7. 7.intervention group in which jaundice will be screened using Picterus JP in addition to VA

Trial Health

87
On Track

Trial Health Score

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

Enrollment
611

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

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

August 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 24, 2023

Last Update Submit

August 9, 2024

Conditions

Neonatal Jaundice

Keywords

neonatal jaundicescreeningdetectionmHealth

Outcome Measures

Primary Outcomes (1)

  • Difference in the proportion of newborns with a positive total serum bilirubin blood test

    Bilirubin blood level \> 15 mg/dl

    6 months

Secondary Outcomes (6)

  • Extent to which researchers are capable of successfully recruiting participants (Recruitment capability)

    6 months

  • Extent to which Picterus JP adapts to different conditions

    6 months

  • Extent to which Picterus JP aligns with the current care routine

    6 months

  • Extent to which health care providers use Picterus JP with fidelity

    6 months

  • Extent to which Picterus JP can be used with the current infrastructure

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Standard care

NO INTERVENTION

Participants assigned to this group will be screened for neonatal jaundice with the current used method consisting in visual assessment

Standard care + Picterus JP

EXPERIMENTAL

Participants assigned to this group will be screened for neonatal jaundice with the current used method consisting in visual assessment and the smartphone app Picterus JP

Device: Picterus JP

Interventions

Picterus JPDEVICE

Picterus JP is a medical device consisting in a smartphone app which is use to take images of the skin of the newborn, a color calibration card that must be placed in the newborn chest to calibrate color and lighting in the images and a server to analyze data and estimate bilirubin level

Standard care + Picterus JP

Eligibility Criteria

Age1 Day - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term healthy newborns
  • Age 1-14 days
  • Gestational age \>37 weeks
  • Birthweight \> 2000 grams

You may not qualify if:

  • Inborn diseases
  • Transferred to pediatric wards for non-related neonatal jaundice treatment
  • Have received phototherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Rural Bienestar No 36

Tlacolula, Oaxaca, 70400, Mexico

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

October 10, 2023

Study Start

January 1, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Locations

ME(1)