NCT01833091

Creating an Artificial Night on Physiological Changes in Preterm Infants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Mashhad University of Medical Sciences · Academic / Other
• Sex: All
• Age: 30 Weeks – 34 Weeks
• Healthy volunteers: Accepted

Summary

Effects of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants. Introduction:Nowdays,with medical advances in intensive care increased chance of survival in premature infants.One of the major concerns exposure to high light levels in neonate \& subsequent it is increase in metabolism rate.So,this study was conducted to determine the effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants. Methods: This is a randomized clinical trial dual group study, 38 preterm infants (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the weight and the weight of each group were randomized into artificial night(dark period was from 19 to 7 during incubator was covered with linen cloth \& light period was from 7 to 19 removed the cover) and control groups(continuous lighting). Mothers \& infants through questionnaires,interviews,observation \& document completion, changes in physiologic \& weight befor entering the study \& then physiologic changes twice a day,weight \& feeding tolerance were collected daily.Data were analyzed using spss v.16 software.

Conditions

• Physiologic Changes

Interventions

Type	Name	Description
OTHER	artificial night	Infants in the intervention group received light cyclic with pattern 12 hours. Light period was from 7 to 19 during which the infants were put in the normal environmental light and dark period was from 19 to 7 during which was the infants' incubator was covered with linen cloth. The vital signsand \& arterial oxygen saturation of the infants in the intervention group were controlled before covering the incubator i.e. at 19. Also, the infant's vital signs were again monitored at 7 am.The infant weighed in every day at 7 am during the 10 days of study. Feeding tolerance was daily determined at 8 am, using nasogastric tube or orogastric tube to control residue as well as to review the presence or absence of abdominal distention, vomiting.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2013-04-16
• Last updated: 2013-04-16