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

Not Applicable

Recruitment & Eligibility

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

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

Primary Outcome Measures

Name	Time	Method
1. Mean timing baby first fed mother breast milk post-birth <br/ ><br>2. Mean time to mother first breast stimulation via first breast milk expression or baby first put to breast <br/ ><br>3. Mean number of mother breast milk feeding sessions (direct or expressed) in the last 24 hours <br/ ><br>4. Mean number of breast milk expression sessions in the last 24 hours <br/ ><br>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)). <br/ ><br>2. One time (Immediately after the enrolment and then daily till 14 days or discharge (Whichever is earlier)). <br/ ><br>3. Daily till 14 days or discharge (Whichever is earlier). <br/ ><br>4. Daily till 14 days or discharge (Whichever is earlier). <br/ ><br>5. Last day i.e. 14th day or on the day of discharge whichever is earlier.

Secondary Outcome Measures

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