New feeding support for tiny babies tested in three countries
NCT ID NCT06390943
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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632 people
The number who actually took part.
- Started
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May 2024
- Finished
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Feb 2026
- Lead sponsor
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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
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1 minute and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Amana Regional Hospital
Dar es Salaam, Tanzania
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Bwaila District Hospital
Lilongwe, Malawi
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Ganesh Shankar Vidyarthi Memorial Medical College
Kanpur, India
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Institute of Medical Sciences, Banaras Hindu University
Varanasi, India
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King George Medical College
Lucknow, India
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