Oropharyngeal Administration of Mother's Colostrum for Premature Infants (NS-72393-360)
Condition: Infection; Enterocolitis, Necrotizing; Ventilator-associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Enterocolitis; Enterocolitis, Necrotizing; Premature Birth
Study type: Interventional

Summary: 
      Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own
      mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in
      immune factors which may provide immunostimulatory effects when administered oropharyngeally
      to extremely premature infants during the first weeks of life. The investigators hypothesize
      that infants who receive oropharyngeal mother's colostrum and milk will have significantly
      lower rates of infection and improved health outcomes, compared to infants who receive a
      placebo.
    

Detailed description: 
      Extremely premature (BW<1250g) infants are at high risk for morbidity and mortality. Own
      mother's colostrum (OMC) and milk (OMM) protect against neonatal morbidity and are rich in
      immune factors which may provide immunostimulatory effects when administered oropharyngeally
      to extremely premature infants during the first weeks of life. This 5-year
      placebo-controlled, double-blind randomized controlled trial will evaluate the safety,
      efficacy and health outcomes of oropharyngeal administration of OMC/OMM in a sample of 622
      (total patients enrolled) extremely premature infants with the following aims: Aim 1. To
      determine if oropharyngeal administration of OMC/OMM to extremely premature infants will
      reduce the risk of late-onset sepsis or death as the primary outcome, and necrotizing
      enterocolitis and ventilator-associated pneumonia as pre-planned secondary outcomes. Aim 2:
      To determine if extremely premature infants who receive OMC/OMM via the oropharyngeal route
      have a shorter time to reach full enteral feeds and a shorter length of hospital stay. Aim 3:
      To determine if oropharyngeal administration of OMC/OMM will have immunostimulatory effects
      for extremely premature infants, as measured by (A) enhancement of gastrointestinal (fecal)
      microbiota, (B) improvement in antioxidant defense maturation or reduction of pro-oxidant
      status, and (C) maturation of immunostimulatory effects as measured by changes in urinary
      lactoferrin. Results will confirm whether extremely premature infants demonstrate a
      host-immune response to this intervention and whether there is a beneficial effect on common
      morbidities in these high risk patients.
    

Intervention name(s): oropharyngeal mother's milk; oropharyngeal sterile water
Intervention type(s): Other; Other
Intervention description(s): Application of 0.2 mL of own mother's milk onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age; Application of 0.2 mL of sterile water onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: oropharyngeal; colostrum; mother's milk; premature; neonate; infection; necrotizing enterocolitis; ventilator-associated pneumonia; breastmilk; human milk; late-onset sepsis; microbiome; antioxidant; enteral feeds