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A clinical trial to study the effects of a feeding method in preterm newborns with cessation of breathing and gastroesophageal reflux

Evaluation of transpyloric feeding in apnea of preterm neonates with gastroesophageal reflux in a tertiary care hospital of Kolkata, India

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/03/005656
Enrollment
16
Registered
2015-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Gastroesophageal reflux associated apnea of preterm neonates

Interventions

Intervention1: Transpyloric tube feeding: The intervention will consist of transpyloric tube feeding in preterm neonates with apnea clinically suspected to be associated wuth gastroesophageal reflux.

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria (i) Intramural live births. (ii) Gestational age less than 37 weeks. (iii) Babies on enteral feeding (partial/complete) with human milk with recurrent apnea clinically suspected to be due to gastroesophageal reflux. (iv) Parents or caregivers or their legally acceptable/ authorised representatives consenting to take part in the study.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: (i) Extramural live births (ii) Neonates not on enteral feeds due to any reason (iii) Neonates on invasive mechanical ventilation (iv) Neonates with major congenital anomalies (v) Neonates with apnea diagnosed to be due to conditions other than gastroesophageal reflux. Thus, preterm neonates with apnea diagnosed to be due to sepsis, metabolic disturbances, electrolyte imbalances, patent ductus arteriosus, intracranial hemorrhage etc will be excluded. (vi) Parents or caregivers or their legally acceptable/ authorised representatives not consenting to take part in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of episodes of apneaTimepoint: 48 hours

Secondary

MeasureTime frame
Incidence of gastrointestinal disturbancesTimepoint: 72 hours;Incidence of necrotizing enterocolitisTimepoint: 72 hours;All cause mortalityTimepoint: 72 hours

Countries

India

Contacts

Public ContactDr Tamoghna Biswas

Medical College Kolkata

tsabui@gmail.com9830196110

Outcome results

None listed

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