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Parental Infant BondingNCT02518997

Effects of Reading to Preterm Infants on Baby and Parents' Well Being

A study testing Parental Reading Aloud in people with Parental Infant Bonding and Cardio-respiratory Stability in Preterm NICU Infants, run by Georgetown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. Read more about this study

Who is it for?
Ages 7 days to 40 weeks
What is being tested?
Parental Reading Aloud
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Oct 2014to Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 days to 40 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants between 26 0/7 34 6/7 weeks corrected gestational age (CGA) at the time of enrollment, [gestational age stated as # of weeks plus the number of days of the next week completed, the days are expressed as a fraction of a 7 day week (CGA= GA at birth + days of life)] rationale: 26 0/7 is the age at which the auditory system is generally well formed but still immature. Infants born at less than 26 0/7 weeks GA can be enrolled once they reach 26 0/7 weeks.
  • Infants at least 7 days of life to allow for transition to extrauterine life.
  • Parental Inclusion Criteria
  • Agreement to the study with signed Informed Consent Form and HIPAA Authorization
  • Visits on a regular basis (at least 3 times per week)
  • Is literate (able to read)

Who cannot join

  • Infants deemed too ill to participate by the primary care team at one week of age, although those infants may be enrolled at a later date when they are stabilized with the approval of the clinical care team,
  • infants with congenital hearing loss,
  • chromosomal abnormalities,
  • infants not expected to survive.
  • Parents Exclusions Does not read or is uncomfortable reading aloud. (unlikely to sign informed consent if this is the case)
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Reading to children is believed to be beneficial to cognitive and mental development.This study will examine the response of premature Neonatal Intensive Care Unit (NICU) infants to bedside reading by measuring changes in heart rate, blood pressure, breathing and oxygen levels. The investigators will follow rates of common preterm health issues while in the hospital and time to hospital discharge. Effects of bedside reading on parental stress and infant bonding will be measured and compared to usual rates of these indicators to determine if reading to babies reduces stress and enhances bonding.

Read the detailed description

The NICU at Georgetown University Hospital cares for approximately 100 infants per year in the study population between 26-34 weeks gestation. We have a patient population where parental daily visits are the norm, allowing for a study using live voices.

The investigators will approach parents of infants who meet entry criteria who are nearing one week of age after consultation with the clinical care team to determine stability. All preterm infants admitted to the NICU who are deemed stable enough to participate by the primary team will be approached for study participation.

After parental consent is obtained, the parents will be given an initial questionnaire to assess demographic data such as parental education and attitudes regarding reading to infants. Parents will be given a picture book with rhythmic sound patterns for reading aloud to their infant. Bedside nurses will help guide parents to the best time for infant reading. Time of parent reading (start and stop time) will be recorded in the infant's chart. Mothers and fathers will be allowed to read to the infant at separate reading times. A decibel monitor placed at the opening of the incubator will display the decibel level of parental voice.

Parents will be asked to read to their babies for at least 15 minutes but not more than 60 minutes per session. The total reading time for any 24 hour period can be up to 90 minutes.

Reading will occur with the infant in an incubator, in an open warmer or crib or while being held by parents. If the infant is in an incubator, parents will read with the portal closest to the parent open. For those babies who are in an open crib or warmer the parents will read close enough to the bedside so as not to be heard by neighboring patients. In older infants who are stable enough for kangaroo care or are out of bed being held by parents, reading can occur at those times, if desired by the parents. The Infant's location (in incubator, open bed, kangaroo care or parental holding) will be recorded in a study bedside binder.

Parents may also make a 30 minute recording on a digital recording device which can be played back to the baby twice per day if the parents are not expected to visit and the total reading time has not been met. Nursing staff will alternate between mother and father recorded sessions when neither parent is present and the total reading time for the day has not occurred.

Enrolling 80 infant/parent pairs will allow for subgroup analysis of Cardio Respiratory Events (CREs) in different corrected gestational ages (grouped into two cohorts 26-30 completed weeks and 31-34 completed weeks) and for comparison in effect of maternal and paternal voices. The study will not dictate who reads when both parents are present, but will encourage fathers to read if their visits are less frequent than mother's.

To assess changes in CREs, during NICU admission we will continuously record infant heart rate, respiratory rate, oxygen saturation, and CREs via software capable of downloading data directly from infant monitors used for routine clinical monitoring in the NICU, reducing variations in bedside charting and supplying a more complete documentation of the infant's cardiopulmonary status. Assessment of parental reading impact will be assessed at least three times per week and up to twice per day. Monitoring equipment is limited to recording three infants at one time so number of infants monitored per day will be impacted by total number of infants in the study at one time.

Changes in heart rate, respiratory rate, numbers of desaturation and apnea or bradycardia events will be scored for 3 reading session epochs; one hour before reading, during reading and one hour after parent reading will be measured. We will also compare CRE scores of reading times to CRE scores of similar periods throughout the day (eg 30 minutes before and after feedings). Enrolled infants who require high frequency ventilation will be temporarily withdrawn until the infant returns to conventional ventilation. If an infant is deemed too ill to participate by the primary team due to worsening in clinical status, he or she may be temporarily withdrawn until the primary team decides he/she is again stable enough to participate.

Parent-infant bonding will be assessed via a questionnaire administered four times during the study: before enrollment, at hospital discharge (average expected length of time 6 weeks) and 3-months after discharge. Attitudes toward reading to infants and patterns of reading at home after discharge will also be recorded and compared.

Frequency of parent-infant reading after discharge will be compared to historical controls via survey of families whose infants have been discharged from the NICU prior to the study initiation and exposure to subsequent study-initiated reading education efforts. This control group will be polled for parental education, feelings on reading to infants and frequency of that behavior at home in the first 3 months after hospital discharge to obtain a historical baseline for our study population. Parents of the prospective reading group will receive the same questionnaire at 3 months after discharge and these results will be compared.

Data on CREs will be recorded at multiple time points for the duration of care within an incubator and outcomes followed to hospital discharge, an average of 8 weeks. Parent-infant reading patterns will be followed up to 3 months after hospital discharge.

Being tested
Parental Reading Aloud
Keywords
Preterm Infants, Bedside Reading aloud, Parental wellbeing, Parental Bonding, cardio-respiratory stability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parental Reading AloudOther

    Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring.

Study groups in NCT02518997
Study groupRoleWhat they receive
All enrolled infantsExperimentalAll participants will have Parental Reading Aloud at the prescribed intervals while being monitored for cardio-respiratory stability.
Receives: Other: Parental Reading Aloud

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of Oxygen Saturation Measurements <85%

    Percent of measured oxygen saturations recorded as less than 85%

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2015 (estimated)
  2. Study startOct 2014
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02518997
Sponsor's protocol ID
2014-1464
Status last verified
Jan 2020
First submitted
10 Mar 2015
Last updated
28 Jan 2020
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Parental Reading Aloud in people with Parental Infant Bonding and Cardio-respiratory Stability in Preterm NICU Infants, run by Georgetown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Oxygen Saturation Measurements <85% (time frame: While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.

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