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Improving and testing a care package for small vulnerable infants in facility and community settings

Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Implementation research of an in-facility and community supportive care package - LIFT-UP

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065188
Enrollment
360
Registered
2024-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: NIL: NIL

Sponsors

Harvard University
Lead Sponsor
Community Empowerment Lab
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. LBW (less than 2.5 kg) or preterm (less than 37 weeks) infants admitted in the NICU of the study facility. 2. In-born infants admitted to the NICU within 24 hours of birth. 3. Mother and infant alive during screening 4. Mother consents for herself and infant 5.Women (mothers) who are 18+ years of age 6.All clinical study team members to be included with no exclusions.

Exclusion criteria

Exclusion criteria: 1. Out-born infants referred to study facility NICU. 2. Congenital anomalies or acquired conditions that interfere with feeding or placement of nasogastric or orogastric (NG or OG) tube [e.g., cleft lip or palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, NEC] 3. Severe birth asphyxia 4. Unknown date of birth and or unknown gestational age

Design outcomes

Primary

MeasureTime frame
1. Mean timing baby first fed mother breast milk post-birth 2. Mean time to mother first breast stimulation via first breast milk expression or baby first put to breast 3. Mean number of mother breast milk feeding sessions (direct or expressed) in the last 24 hours 4. Mean number of breast milk expression sessions in the last 24 hours 5. Maternal self-efficacy or confidence (different tools for those who expressed and those who fed directly at the breast)Timepoint: 1. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). 2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). 3. Daily till 14 days or discharge (Whichever is earlier). 4. Daily till 14 days or discharge (Whichever is earlier). 5. Last day i.e. 14th day or on the day of discharge whichever is earlier.

Secondary

MeasureTime frame
1. Mean timing of baby first fed mother breast milk post-NICU admission 2. Management of feeding difficulties 3. Percentage receiving at least 8 hours of KMC in last 24 hours) 4. Any KMC in last 24 hours 5. Percentage Infant fed exclusive MOM in the last 24 hours 6. Mean weight velocity (growth) (g per kg per day)Timepoint: Daily or till the discharge of newborn or 14 days after admission

Countries

India

Contacts

Public ContactVinay Pratap Singh

Community Empowerment Lab

aarti.kumar@celworld.org919936060008

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026