Creating an Artificial Night on Physiological Changes in Preterm Infants

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.

Study Overview

• Status: Completed
• Conditions: Physiologic Changes
• Intervention / Treatment: Other: artificial night

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: intervention; creat light period 12 hours with cover on incubator	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.; Other Names: intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants	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)	1 years

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 12, 2013
• First Posted (Estimate): April 16, 2013

Study Record Updates

• Last Update Posted (Estimate): April 16, 2013
• Last Update Submitted That Met QC Criteria: April 12, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: Artificial Night

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No