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OpenTrials
Completed

NCT Number: NCT02847689

Listening to Mom in the NICU: Neural, Clinical and Language Outcomes

The purpose of this study is to examine whether playing recordings of a mother's voice to her infant while in the hospital nursery is an effective treatment for promoting healthy brain and language development in infants born preterm.

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Key information

Age range

24 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University - Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

About this study

Children born preterm are at-risk for developmental language delays. Language problems in preterm children are thought to be related to neurobiological factors, including injuries to white matter structures of the brain and environmental factors, including decreased exposure to maternal speech in the hospital nursery. There is evidence to suggest that maternal speech input may be important for promoting healthy brain and language development.

Participants will be randomly assigned to one of two study groups. Each infant has a 50% chance of being assigned to the group that will listen to a recording of his/her mother's voice and a 50% chance of being assigned to the group that will not be played a voice recording. Mother's of participating infants will have her voice recorded as she reads a common children's storybook. Recordings will be played to infants each day until s/he is discharged from the hospital. Participation in this study requires that all infants receive up to an additional 10 minutes of brain scans as part of his/her routine clinical magnetic resonance imaging (MRI).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants born preterm at Stanford Children's Hospital between 27 0/7 - 31 6/7 weeks gestational age

Exclusion criteria

  • Congenital anomalies
  • Recognizable malformation syndromes
  • Active seizure disorders
  • History of Central Nervous System infections
  • Hydrocephalus
  • Major sensori-neural hearing loss
  • Likelihood to be transferred from NICU to alternate care facility or home environment prior to 36 weeks PMA
  • Intraventricular Hemorrhage Grades III-IV
  • Cystic periventricular leukomalacia (PVL)
  • Surgical treatment for necrotizing enterocolitis
  • Small for gestational age (SGA) <3 percentile and/or Intra-uterine growth restriction (IUGR) no head sparing
  • Twin-to-twin transfusions

Treatment and study plan

Language Treatment

Behavioral

Recording of a mother's voice reading a children's storybook.

Control treatment

Behavioral

Standard of Care

Other names: Standard of Care

Primary outcomes

  1. White matter mean diffusivity

    Time frame: 36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first

    Mean diffusivity measures the average rate of water diffusion within a given MRI voxel.

Secondary outcomes

  1. Length of hospital stay

    Time frame: Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA)

    Days in hospital since birth and until discharge

  2. Average daily weight gain

    Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

  3. Time (days) to full oral feed

    Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

    days until 100 % of nutrition administered orally

  4. Number of significant apnea and bradycardia events requiring stimulation

    Time frame: measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Listening to Mom in the Neonatal Intensive Care Unit (NICU): Neural, Clinical and Language Outcomes

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jul 28, 2016
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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