Health Condition 1: P789- Perinatal digestive system disorder, unspecified
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
All India Institute of Medical Sciences, Rishikesh