Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants

May 11, 2026 updated by: Shabnam Lainwala, Connecticut Children's Medical Center
Oral feeding is one of the primary functions of the neonatal brain. In preterm infant population, competency at oral feeding is one of the major milestones in preparation for discharge. Mother's voices have been shown to have a net stimulatory effect and premature infants have been found to have increased cardiorespiratory stability after listening to mother's voices. Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Achievement of full oral feedings is directly associated with length of neonatal intensive care unit stay. Extremely low gestational age infants with dysfunctional oral feeding in early childhood have lower cognitive and language skills compared with those with normal oral feedings. Also, previous studies have shown a strong association between oral feeding and infant maturity and behavior state and positive feeding experience. In recent years, there is emerging evidence that non-medical developmental care interventions in the neonatal intensive care units such as kangaroo care, single family rooms, and music and massage therapy may be beneficial for preterm infants and improve their long term neurodevelopmental outcomes. Beneficial effects of exposure to mother's voice and sounds on preterm infants in the neonatal intensive care units are well documented. Our study proposes to examine the association between exposure to mother's voice prior to and during oral feeding and oral feeding volume and rate in preterm infants.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 9 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants born between gestational age of 28 0/7 weeks and 34 6/7 weeks
  • Ready to start oral feeding attempts
  • Taking a total daily oral intake < 50% of feeds on average in 2 days prior to starting intervention
  • Mothers who are English speaking and over 18 years old

Exclusion Criteria:

  • Major congenital anomalies
  • Non-English speaking
  • Family history of suspected congenital hearing loss
  • Failed hearing test in NICU
  • Grade three to four intraventricular hemorrhage or periventricular leukomalacia
  • necrotizing enterocolitis requiring treatment
  • Congenital infections such as cytomegalovirus which can lead to sensorineural hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maternal Voice Exposure
Infants enrolled will be exposed to maternal voice for 20 min immediately prior to being offered oral feedings. This exposure will be conducted 2 times a day until infant starts taking all enteral feeds orally.
Behavioral: Maternal Voice Exposure
Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.
No Intervention: Maternal Voice
Maternal voice delivered to infant in arm 1 by spoken words or recording.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Oral Feedings
Time Frame: Oral feeding proportions were collected for baseline feed 3 hr prior to the intervention, for post intervention feed immediately after the intervention and for follow-up feed 3 hr after the intervention.

Effect of maternal voice immediately prior to feeding on oral feed proportions in preterm infants.

Proportion of oral feeds is defined as the volume of oral intake divided by the prescribed volume for the feeding for each feeding session. The change from baseline to post intervention and follow- up is reported.
Oral feeding proportions were collected for baseline feed 3 hr prior to the intervention, for post intervention feed immediately after the intervention and for follow-up feed 3 hr after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connecticut Children's Medical Center

Investigators

  • Principal Investigator: Shabnam Lainwala, MBBS, PhD, Connecticut Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

December 9, 2020

Study Completion (Actual)

December 9, 2020

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20-026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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