Creating an Artificial Night on Physiological Changes in Preterm Infants

Phase 2

Completed

• Conditions: Physiologic Changes
• Interventions: Other: artificial night

• Registration Number: NCT01833091
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2013-03
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-12
• Last Update Submitted: 2013-04-12
• Study First Posted: 2013-04-16
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Premature newborn infants with gestational age of 30-34 weeks Birth weight of 1200-2200g Taking care and supervision in the incubator to measure weight and grow up Keeping the axillary temperature in the range of 36-37° C Keeping the heart rate in the range of 100 to 160 beats per minute Breast feeding through a nasogastric tube or gastric orally Healthy infants without congenital anomalies No history of taking specific drugs or alcohol by mother during the pregnancy. Mother's lack of addiction

Exclusion Criteria

Illness of the infant (affecting with secondary sepsis, seizures; increased or decreased blood pressure, successive apnea, feeding intolerance or feeding stoppage) Starting phototherapy Discharge of the infant earlier than 10 days Parents' lack of consent with the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	artificial night	creat light period 12 hours with cover on incubator

Primary Outcome Measures

Name	Time	Method
effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants	1 years	physiological changes including:systolic blood pressure \& diastolic blood pressure(mm/hg),resoiratory rate(number of minutes),pulse rate(beats per minute), temperature(° C),arterial oxygen saturation(percent),daily weighting \& comparing it with the previous days(gram),feeding tolerance(residual volume,vomiting,abdominal distention)