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Baby jumpsuit could spot developmental delays in remote areas

NCT ID NCT05782673

Knowledge-focused Sponsor: Helsinki University Central Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a wearable jumpsuit called MAIJU that measures how babies move at home. Researchers will track about 100 infants in rural Malawi from 6 to 18 months old, comparing their motor development with later neurodevelopmental outcomes. The goal is to see if this simple device can reliably assess motor skills in low-income settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MAIJU jumpsuit (wearable device)
What this could lead to
If successful, this could provide a simple, home-based tool to track infant motor development in low-resource settings, helping identify delays early.
What could go wrong
This is an early feasibility study with only 100 infants, so results may not apply broadly. The device may not work well in all rural conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All infants born in the catchment area of Lungwena health center are screened, and the infants are contacted if they fullfil the eligibility criteria.

Ages

4 to 24 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A documented birth date * Birth at about term age, i.e. between 35 and 42 gestation weeks * Mother's ability to speak fluently Chi-Chewa, Chi-Yao or English * Permanent resident of Lungwena Health Centre catchment area * Availability and willingness of the mother and infant during the period of the study * Signed or thumb-printed informed consent by the caregiver of the infant Exclusion Criteria: * Very early birth (at 7th month or earlier) based on mother's information * Infant's congenital malformation or severe illness as judged clinically by a study nurse

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infant development

Contacts and locations

Locations

  • BABA, Clinical Trial Unit, New Children's Hospital

    Helsinki, Finland

  • Kamuzu University of Health Sciences

    Blantyre, 3, Malawi

  • Lungwena Health Center

    Mangochi, Mangochi district, Malawi

  • University of Helsinki

    Helsinki, 00250, Finland

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