The goal of this clinical trial is to study the effect of twice-daily saline enema (SE) in the treatment obstruction of prematurity (MOP) in infants with the birth weight ≤1.25kg. The main questions, the trial aims to answer are
1. To validate the finding of our pilot study which had shown that twice-daily SE reduces the time to reach full enteral feeds in premature infant as compared to premature infant treated with Glycerine Suppository (GS), in a larger cohort. Infant with MOP fails to pass meconium in the first 48 hours of life and develop symptoms and signs like abdominal distension and feed intolerance. 2. The other aims of this study are to test whether the intervention is
1. Effective treatment for MOP 2. Reduce the duration of ICU stay 3. Reduce the rate of necrotizing enterocolitis, sepsis, Total Parenteral Nutrition (TPN) days and number of intravenous catheter days 3. The study also wants to explore the impact of this intervention on the gut microbiome, gut-brain interaction and immune response of the new-born.
Criteria A: For infant presenting with early onset of MOP
Birth weight 500 - 1250 gram
≥ 23 weeks gestation
No BO for 48 hours
Neuromuscular disorder
Moderate or severe asphyxia
Inability to start enteral feeding, which continued for 3 consecutive days before 2 weeks of post-natal age for reasons unrelated to meconium inspissation or its complication
Without parental consent
KK Women's and Children's Hospital
Lead sponsor
Singapore General Hospital
Collaborator
Genome Institute of Singapore
Collaborator
Translational Immunology Institute
Collaborator
Duke-NUS Graduate Medical School
Collaborator