Clinical effects of breast milk on enema-induced meconium evacuation in super premature infants and preterm infants

Not Applicable

Completed

Conditions: Super Premature Infants and Preterm Infants
Neonatal Diseases

Registration Number: ISRCTN17847514

Lead Sponsor: Shengjing Hospital of China Medical University

Brief Summary: 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33902678/ (added 28/04/2021) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38648060/ (added 29/04/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 286

Inclusion Criteria

1. Super premature infants 23W = gestational age <28W and Preterm infants 28W = gestational age <30W
2. Mother provides breast milk 48 hours after birth
3. Normal intestinal motility (as assessed by the team of clinical experts)
4. Parental agreement to participate in the study

Exclusion Criteria

1. Congenital digestive tract abnormalities, such as congenital gastrointestinal dysfunction
2. Congenital malformations, gastrointestinal malformations, such as rectal anal deformities
3. Abnormal hemodynamics, such aspoor intestinal motility, diarrhea, intussusception, and necrotizing enterocolitis (NEC)
4. Anorectal mucosal injury
5. Surgery within 48 hours after birth
6. Severe coagulopathy:
6.1 International standardization ratio >1.4
6.2 Partial thromboplastin time >39s
6.3 Fibrinogen <1.00g/L
6.4 Platelet count <100×109/L
7. Sepsis, symptomatic patent ductus arteriosus (PDA)
8. Neutropenia (absolute number of neutrophils <0.5×109/L)
9. Blood incompatible hemolytic disease of the newborn, requiring immediate blood exchange
10. Mother with severe disease or using medicine that is contraindicated during lactation
11. Researchers to exclude anyone that they felt would not be a good trial participant

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time from birth to the last meconium evacuation:<br>This trial will use the standard infant meconium evacuation form. Nursing personnel will be trained to correctly identify the infant’s meconium, transitional meconium, and normal feces. Detailed information on the evacuation and characteristics of each meconium will be recorded, and questionable meconium photos will be recorded and discussed in group meetings. <br>2. Time to achieve total enteral feeding in super premature infants and preterm infants (when the infant tolerates a volume of 180 ml/kg/day for at least 24 h or undergoes weight gain greater than 20-25 g/d in 24 h)

Secondary Outcome Measures

Name	Time	Method
1. Stage II or III necrotizing enterocolitis (NEC, Bell standard)<br>2. Hospitalization days<br>3. Body weight at discharge<br>4. Duration of total parenteral nutrition<br>5. Cholestasis, measured 2 weeks after birth in two groups:<br>5.1 Serum binding bilirubin concentration > 1.0 mg/dL (17.1 mmol/L)<br>5.2 Serum total bilirubin < 5.0 mg/dL (85.5 mmol/L) or >20%<br>5.3 Total bilirubin concentration >5.0 mg/dL (85.5 mmol/L)<br>6. Any adverse events reported: nosocomial infection, nosocomial death, retinopathy of prematurity (ROP, any stage), chronic lung disease (CLD), requirement of ventilatory support or oxygen after a corrected gestational age of 36 weeks , intraventricular hemorrhage (IVH, grade 2 and above), bronchopulmonary dysplasia (BPD), late-onset sepsis (LOS), diarrhea, colon perforation, malabsorption, rectal bleeding, and rectal trauma