Skip to content

Route of tube feeding in tiny babies

Orogastric Versus Nasogastric Feeding Tube Placement in Preterm Neonates: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022579
Enrollment
100
Registered
2019-12-31
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: P789- Perinatal digestive system disorder, unspecified

Interventions

Intervention1: Orogastric placement of feeding tube: Spontaneously breathing early preterm neonates (â?¤34 weeksâ?? gestation) not requiring any respiratory support, not accepting direct breastfeeding

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Spontaneously breathing early preterm neonates (<=34 weeksâ?? gestation) not requiring any respiratory support, not accepting direct breastfeeding/cup feeding and dependent on tube feeding for enteral nutrition

Exclusion criteria

Exclusion criteria: 1. Major congenital malformations 2. Neuromotor abnormalities 3. Presence of other causes of hypoxic episodes other than prematurity (e.g. sepsis, perinatal asphyxia, encephalopathy, intracranial hemorrhage >=grade II) 4. Failure to obtain parental consent

Design outcomes

Primary

MeasureTime frame
Combined hourly incidence of hypoxia (defined as fall in SpO2 to 80% lasting for at least 10 seconds to 3 minutes) and bradycardia (defined as a fall in heart rate by more than a third of an infantâ??s baseline heart rate, lasting for at least 4 seconds).Timepoint: Outcome will be assessed once the infant starts accepting entire enteral nutrition through direct breastfeeding and/or cup feeding.

Secondary

MeasureTime frame
1. Number of tube changes required per day due to inadvertent tube removal or displacement 2. Episodes of apnea per day 3. Time to establish full oral feeds 4. Time to regain birth weight 5. Rates of weight gain, linear growth and head growth up to 36 weeks postmenstrual age or discharge, whichever is earlier Timepoint: At the time of accepting entire enteral nutrition through direct breastfeeding and/or cup feeding and at hospital discharge.

Countries

India

Contacts

Public ContactSriparna Basu

All India Institute of Medical Sciences, Rishikesh

drpoonamujn@gmail.com8527106059

Outcome results

None listed

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