Study to Compare Continuous Feeding with Bolus Feeding in Preterm Infants Equal to Or Less Than 1250 Grams

Continuous feeding followed by intermittent bolus feeding versus intermittent bolus feeding in =1250 Gram Infants: A Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060524

Enrollment

Registered

2023-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: P071- Other low birth weight newborn

Interventions

Intervention1: Continuous Feeding Followed By Intermittent Bolus Feeding: This study is aimed to compare the continuous feeding followed by intermittent bolus feeding method with the intermittent feed

Eligibility

Inclusion criteria

Inclusion criteria: Inborn infants between 600 and less than or equal to 1250 gram birth weight with the decision to start enteral feeding within 96 hours of birth

Exclusion criteria

Exclusion criteria: i)Major congenital malformations or suspected/proven syndromic infants ii)Antenatally diagnosed surgical conditions prohibiting the start of enteral feed iii)Suspected or confirmed gastrointestinal obstruction iv)Severe perinatal asphyxia (Apgar v)Less than 600 gram birth weight vi)No reasonable chance of survival

Design outcomes

Primary

Measure	Time frame
Time to reach full feed (150 ml/kg/day for at least 48 hours) between the continuous followed by intermittent feeding group and the intermittent feeding group in less than or equal to 1250 gram infants.Timepoint: Day of life at which the enrolled infant achieves 150 ml/kg/day feed or more (for at least 48 hours)	—

Secondary

Measure	Time frame
1.Incidence of feed intolerance 2.Incidence of necrotizing enterocolitis stage 2 or more 3.Time to regain birth weight 4.All cause mortality(In hospital) 5.Anthropometry at discharge (Weight, length, Occipitofrontal circumference) 6.Duration of hospital stay(in days) 7.Incidence of Bronchopulmonary dysplasia 8.PDA requiring medical and or surgical treatment 9.ROP any stage 10.ROP requiring Laser or Anti VEGF or both 11.IVH any grade and severe grade ( grade 3 and grade 3 with parenchymal extension) 12.Incidence of Periventricular leukomalacia 13.Episodes of Culture positive sepsis 14.Episodes of Culture negative sepsis 15.Survival without major morbidity Timepoint: till diacharge or death of the enrolled infant	—

Measure

Time frame

1.Incidence of feed intolerance 2.Incidence of necrotizing enterocolitis stage 2 or more 3.Time to regain birth weight 4.All cause mortality(In hospital) 5.Anthropometry at discharge (Weight, length, Occipitofrontal circumference) 6.Duration of hospital stay(in days) 7.Incidence of Bronchopulmonary dysplasia 8.PDA requiring medical and or surgical treatment 9.ROP any stage 10.ROP requiring Laser or Anti VEGF or both 11.IVH any grade and severe grade ( grade 3 and grade 3 with parenchymal extension) 12.Incidence of Periventricular leukomalacia 13.Episodes of Culture positive sepsis 14.Episodes of Culture negative sepsis 15.Survival without major morbidity Timepoint: till diacharge or death of the enrolled infant

—

Countries

India

Contacts

Public ContactDr Vijaykumar

AIIMS Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results

None listed

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