Trial Outcomes & Findings for Effects of Reading to Preterm Infants on Baby and Parents' Well Being (NCT NCT02518997)

NCT ID: NCT02518997

Last Updated: 2020-01-28

Results Overview

Percent of measured oxygen saturations recorded as less than 85%

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks
• Results posted on: 2020-01-28

Participant Flow

Participant milestones

Measure	All Enrolled Infants All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Enrolled Infants n=18 Participants All participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability. Parental Reading Aloud: Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring.
Age, Categorical <=18 years	18 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants
Age, Continuous	27.8 days n=18 Participants
Sex: Female, Male Female	10 Participants n=18 Participants
Sex: Female, Male Male	8 Participants n=18 Participants
Region of Enrollment United States	18 participants n=18 Participants
gestational age at birth	25.8 weeks n=18 Participants
postmenstrual age at study entry	30 weeks n=18 Participants
Birth weight	831 grams n=18 Participants

PRIMARY outcome

Timeframe: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks

Population: All enrolled infants had measured oxygen saturations at 4 time periods: during reading exposure and 3 hours before reading, 1 hour before reading and 1 hour after reading

Percent of measured oxygen saturations recorded as less than 85%

Outcome measures

Measure	All Enrolled Infants n=23986 Oxygen saturation measurements Infants exposed to parental reading-all enrolled infants	Infants 3 Hours Before Reading n=23921 Oxygen saturation measurements Infants with oxygen saturations measured 3 hours before reading exposure All enrolled infants	Infants 1 Hour Before Reading Exposure n=23030 Oxygen saturation measurements All enrolled infants. Infants with oxygen saturations measured 1 hour before reading exposure	Infants 1 Hour After Reading Exposure n=23198 Oxygen saturation measurements Infants with oxygen saturation data measured 1 hour after reading exposure All enrolled infants
Percent of Oxygen Saturation Measurements <85%	15.2 Percent Oxygen saturation measurements Interval 0.0 to 62.1	16.94 Percent Oxygen saturation measurements Interval 0.0 to 70.9	17.65 Percent Oxygen saturation measurements Interval 0.0 to 64.6	14.39 Percent Oxygen saturation measurements Interval 0.0 to 87.0

Adverse Events

All Enrolled Infants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Scala

Stanford University

Phone: 650-723-5711

Email: mscala@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place