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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02847689
• Other study ID #: 32638
• Secondary ID: 1K99HD084749-01A
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 1, 2021
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 31 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Language Treatment
Recording of a mother's voice reading a children's storybook.
• Control Treatment
Standard of Care

Locations

Country	Name	City	State
United States	Stanford University - Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Average daily weight gain		measured daily and beginning at start of treatment and until end of treatment, approximately 37-40 weeks PMA
Secondary	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
Secondary	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