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

NCT02847689 | Completed DMC

• 2 other identifiers: 326381K99HD084749-01A1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Birth

Keywords

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Length of hospital stay

  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

• Time (days) to full oral feed

  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

Study Arms (2)

Language Treatment Arm

EXPERIMENTAL

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

Control Treatment Arm

SHAM COMPARATOR

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

Interventions

Language Treatment BEHAVIORAL

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

Language Treatment Arm

Control Treatment BEHAVIORAL

Standard of Care

Also known as: Standard of Care

Control Treatment Arm

Eligibility Criteria

• Age: 24 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stanford University - Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Katherine E Travis, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2016
• Primary Completion: June 12, 2019
• Study Completion: October 1, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (1)