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New feeding support for tiny babies tested in three countries

NCT ID NCT06390943

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a package of care to help low birthweight or preterm babies in India, Malawi, and Tanzania feed better and grow. The care included support for mothers to breastfeed, kangaroo mother care (skin-to-skin contact), and hygiene practices, both in the hospital and at home after discharge. 632 babies and their mothers took part, and researchers measured feeding habits and growth to see if the package worked.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

632 people

The number who actually took part.

Started

May 2024

Finished

Feb 2026

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.

Ages

1 minute and older

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.

OBJECTIVE 1 (FACILITY-BASED) Inclusion criteria Infants * Low birthweight (≤2.5kg) or preterm (\<37 weeks) infants admitted to NICU at study facility * In-born infants admitted to the NICU within 24 hours of birth) * Mother and infant alive during screening * Mother consents for herself and infant * Women (mothers) who are age of majority: Tanzania and India: 18+; Malawi: 16-17 and married OR 18+ Healthcare providers * Healthcare provider who was trained to deliver the facility-based FSP+ * Healthcare provider consents for him/herself Exclusion criteria Infants * Out-born infants referred to study facility NICU * Congenital anomalies or acquired conditions that interfere with feeding or placement of nasogastric/ orogastric (NG/OG) tube \[e.g., cleft lip/palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, necrotizing enterocolitis\] * Severe birth asphyxia * Unknown date of birth and unknown gestational age OBJECTIVE 2 (TRANSITION-TO-HOME) Inclusion criteria Infants * Infants in India-Uttar Pradesh site * LBW (\<2.5kg) or preterm (\<37 weeks) infants discharged from a study facility and fulfilling all objective 1 inclusion criteria (exposed to objective 1 intervention) * Lives within catchment areas of study facility (50km) * Mother intends to stay in the catchment areas for 3 months post-birth with infant Community providers * Community provider who was trained to deliver the transition-to-home FSP+. * Community provider consents for him/herself Exclusion criteria Infants * Not screened and was not exposed to objective 1 intervention (and meet all eligibility criteria) * Lives outside the defined catchment area * Mother does not intend to stay in the catchment areas for 3 months post-birth with infant Community providers -Community provider who was not trained to deliver the transition-to-home FSP+.

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Contacts and locations

Locations

  • Amana Regional Hospital

    Dar es Salaam, Tanzania

  • Bwaila District Hospital

    Lilongwe, Malawi

  • Ganesh Shankar Vidyarthi Memorial Medical College

    Kanpur, India

  • Institute of Medical Sciences, Banaras Hindu University

    Varanasi, India

  • King George Medical College

    Lucknow, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.