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The effect of early oral probiotics prescription in very low birth weight (VLBW) infants

The effect of early oral probiotics prescription on feeding intolerance, regain birth weight and secondary outcomes in very low birth weight (VLBW) infants

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220505054746N1
Enrollment
300
Registered
2022-08-04
Start date
2022-08-23
Completion date
Unknown
Last updated
2022-08-29

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

Conditions

Condition 1: Very Low Birth Weight. Condition 2: 1_2.499 weight. Condition 3: feeding intolerance. Condition 4: Abdominal distension. Condition 5: vomiting. Condition 6: Digestive bleeding. Condition 7: necrotic enterocolitis. Condition 8: Sepsis. Extremely low birth weight newborn Other low birth weight newborn Neonatal difficulty in feeding at breast P14 P11 P54.3 P77 P36.9

Interventions

Intervention 1: Intervention group: early administration of oral probiotics in infants with very low birth weight. In this study, infants with very low birth weight from the first day of birth in the

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 2 Days

Inclusion criteria

Inclusion criteria: Hospitalization in NICU ward Born weight less than 1500 gr Stable hemodynamic status Ability to enteral nutrition Parent's written consent

Exclusion criteria

Exclusion criteria: Dissatisfaction of parents Impossibility of starting standard nutrition for neonate Existence of any congenital anomalies in neonate Neonate's CPR need in labor room Unstable clinical status Being a child of mothers with substance abuse disorders Severe abdominal distension or peptic hemorrhage Immunodeficiency in the family of neonate Congenital enteral perforation or atresia Complete forbidding of oral feeding

Design outcomes

Primary

MeasureTime frame
Feeding intolerance. Timepoint: In each feeding time. Method of measurement: Checklist.

Secondary

MeasureTime frame
Reach to born weight. Timepoint: Daily. Method of measurement: The weight of the infant will be assessed in terms of grams (in grams) until the clinical condition stabilizes and then daily until the day of discharge from the hospital. At the end of the weighting process, each premature infant will be assessed using Fenton growth charts. All measurements will be performed with a digital scale for fixed infants with the help of a researcher and will be recorded in a checklist created by the researcher.;Sepsis. Timepoint: Daily. Method of measurement: Based on having clinical and specific symptoms of sepsis (including irritability of the baby, rapid breathing or apnea, changes in the skin color of the baby, diarrhea, poor sucking, poor feeding) and positive result of blood culture and CRP result recorded in the checklist in daily evaluations.;Necrotic Enterocolitis. Timepoint: Daily. Method of measurement: Based on having clinical and specific symptoms of Necrotizing Enterocolitis (including lethargy, increased volume of food residue, bloody or bilious vomiting, ileus, persistent abdominal distension, bloody stools, symptoms of peritonitis and shock) and the Bells scale, which is evaluated in the checklist designed by the researcher.;Time of hospitalization. Timepoint: Daily. Method of measurement: Checklist.;Time to reach total nutrition. Timepoint: Daily. Method of measurement: The days required to reach enteral nutrition of 100 milliliter per kilogram per day are evaluated with the checklist made by the researcher.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Heydari

Shahid Beheshti University of Medical Sciences

f.heydari@qums.ac.ir+98 28 3367 3082

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026