Immunomodulatory Effect of Oropharyngeal Administration of Mother Colostrum in Preterm Neonates

Title: Immunomodulatory Effect of Oropharyngeal Administration of Mother’s Colostrum In Preterm Neonates.

Rationale: Due to an immature gastrointestinal tract and comorbidities preventing enteral feedings, delivering colostrum to preterm infants through the enteral route is challenging. Oropharyngeal administration of colostrum emerges as a potential option.

Objectives:

Primary objective: To compare the mean concentrations of serum immunoglobulin A (IgA) following oropharyngeal administration of mother’s colostrum against a control group during the first 5 days of life in preterm neonates with gestational age between 30-34 weeks.

Secondary Objectives:

1. To compare the mean concentrations of serum immunoglobulins (IgG and IgM) and serum inflammatory markers (IL-6, TNF alpha) in both groups.

2. To compare the proportion of feed intolerance and necrotizing enterocolitis in both groups.

Study Design: Open label randomized controlled trial.

Study Duration: April 2024 to August 2025 (17 months duration).

Participants:

Inclusion Criteria : Preterm neonates with 30-34 weeks of gestational

age, admitted in the NICU.

Exclusion criteria:

1. Neonates on enteral feeding.

2. Neonates who received blood transfusions during the study period.

3. Major congenital anomalies.

4. Neonates born to HIV positive or Hepatitis B positive or Hepatitis C positive mothers.

5. Neonates born to mothers who are on any antipsychotics or chemotherapeutic agents.

Procedures : Oropharyngeal administration of 0.2 ml of colostrum will occur every 4 hours for 5 days, starting within 24 hours after birth. Blood samples will be collected on day 1 and day 5.

Outcome Measures :

Primary Outcome: The mean concentrations of serum IgA in both groups.

Secondary Outcomes:

1. The mean concentrations of serum immunoglobulins (lgG. IgM) and serum inflammatory

markers (IL-6 & TNF alpha) in both groups.

2. The proportion of feed intolerance and necrotizing enterocolitis in both groups.

Sample Size: 76 Preterm neonates divided into : the colostrum group and the control group.

Statistical Analysis: Quantitative variables will be described as mean (SD)/median (IQR). Between-group and within-group comparisons of mean will be conducted through unpaired t-test and paired t-test respectively. For comparing medians, Mann Whitney U test will be used. For comparing qualitative variables Chi square test will be used. P value <0.05 will be considered as significant.