Effect of Right Lateral Position on Ventilated Preterm Neonates

Ain Shams University

Status: Completed

Conditions: Gastro Esophageal Reflux

Treatments: Behavioral: positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03258528

Neonatal Reflux

Details and patient eligibility

About

Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. Study design: This randomized controlled trial was conducted on 60 ventilated preterm neonates < 35 weeks. They were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured.

Full description

Objective: to evaluate the effect of right lateral positioning in comparison with supine positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents in ventilated preterm neonates. Study design: This randomized controlled trial was conducted on 60 ventilated preterm neonates < 35 weeks. They were randomized into 2 groups; one group composed of 30 neonates that were nursed in right lateral position for 6 hours while the other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured. Ventilatory settings were observed before and during the intervention and neonates were followed up for development of bronchopulmpnary dysplasia (BPD).

Enrollment: 60 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A total of 60 preterm neonates < 35 weeks gestational age were enrolled in the study, Inclusion criteria were tracheal intubated mechanically ventilated neonates for more than 72 hours, feeding >30ml/kg/day via nasogastric tube.

Exclusion criteria

• Neonates with perinatal asphyxia, intracranial hemorrhage grade 3 or 4, periventricular leukomalacia, major congenital anomalies, gastrointestinal anomalies such as tracheoesophageal fistula, or necrotizing enterocolitis , receiving xanthine derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedatives were excluded.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

right lateral position group

Active Comparator group

Description:

Neonates kept in the right lateral position for 6 hours with head tilted 30 degree upward with rolled towel supports the infant back at 90 degree angle on the bed.

Treatment:

Behavioral: positioning

supine position group

Active Comparator group

Description:

Neonates kept in supine position for 6 hours with head tilted 30 degrees upward. Infants were fed while in their positions via feeding tube.

Treatment:

Behavioral: positioning