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

Listening to Mom in the Neonatal Intensive Care Unit (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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Behavioral: Language Treatment; Behavioral: Control Treatment

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University - Lucile Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Language Treatment Arm; An infant participant randomized to the language treatment arm will be played recordings of his/her mother's voice 2-3 hours daily in the intermediate care nursery until discharge.	Behavioral: Language Treatment; Recording of a mother's voice reading a children's storybook.
Sham Comparator: Control Treatment Arm; An infant participant randomized to the control treatment arm will receive standard of care. Standard of care does not include being played recordings of his/her mother's voice while admitted to the intermediate care nursery. However, an infant randomized to the control treatment will have the same auditory equipment placed in his/her isolette or crib as an infant randomized to the Language Treatment Arm.	Behavioral: Control Treatment; Standard of Care; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White matter mean diffusivity	Mean diffusivity measures the average rate of water diffusion within a given MRI voxel.	36-37 weeks post-menstrual age or at time of hospital discharge, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time (days) to full oral feed	days until 100 % of nutrition administered orally	measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Length of hospital stay	Days in hospital since birth and until discharge	Days in hospital since birth and until discharge, average range is 37-40 weeks postmenstrual age (PMA)
Average daily weight gain		measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Number of significant apnea and bradycardia events requiring stimulation		measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Katherine E Travis, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): June 12, 2019
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy Complications; Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 32638; 1K99HD084749-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED