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

Clinical effects of breast milk on enema-induced meconium evacuation in super premature infants and preterm infants: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17847514

Enrollment

294

Registered

2019-09-14

Start date

2019-09-20

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Super Premature Infants and Preterm Infants Neonatal Diseases Super Premature Infants and Preterm Infants

Interventions

We will recruit 294 eligible subjects and stratify them into three groups according to gestational age. The study subjects will be assigned to the intervention group and the control group through bloc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Time from birth to the last meconium evacuation: 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. 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)	—

Measure

Time frame

1. Time from birth to the last meconium evacuation: 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. 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)

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Secondary

Measure	Time frame
1. Stage II or III necrotizing enterocolitis (NEC, Bell standard) 2. Hospitalization days 3. Body weight at discharge 4. Duration of total parenteral nutrition 5. Cholestasis, measured 2 weeks after birth in two groups: 5.1 Serum binding bilirubin concentration > 1.0 mg/dL (17.1 mmol/L) 5.2 Serum total bilirubin 20% 5.3 Total bilirubin concentration >5.0 mg/dL (85.5 mmol/L) 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	—

Measure

Time frame

1. Stage II or III necrotizing enterocolitis (NEC, Bell standard) 2. Hospitalization days 3. Body weight at discharge 4. Duration of total parenteral nutrition 5. Cholestasis, measured 2 weeks after birth in two groups: 5.1 Serum binding bilirubin concentration > 1.0 mg/dL (17.1 mmol/L) 5.2 Serum total bilirubin 20% 5.3 Total bilirubin concentration >5.0 mg/dL (85.5 mmol/L) 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

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Countries

China

Contacts

Public ContactLi Gai

123742765@qq.com+86-15524273226

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026