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

NCT05181020 | Completed

• 1 other identifier: 20-026
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Enteral Feeding

Keywords

Maternal Voice

Outcome Measures

Primary Outcomes (1)

• Oral feeding volume

  Effect of maternal voice immediately prior to feeding on oral feeding volumes in preterm infants

  Through study completion, average 40 weeks post menstrual age

Study Arms (1)

Maternal Voice Exposure

EXPERIMENTAL

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

Interventions

Maternal Voice Exposure BEHAVIORAL

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.

Maternal Voice Exposure

Eligibility Criteria

• Age: 28 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (1)

• Chhikara A, Hagadorn JI, Lainwala S. Effect of maternal voice on proportion of oral feeding in preterm infants. J Perinatol. 2023 Jan;43(1):68-73. doi: 10.1038/s41372-022-01493-4. Epub 2022 Aug 18.

  PMID: 35982244 DERIVED

Study Officials

• Shabnam Lainwala, MBBS, PhD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Attending Neonatologist

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 6, 2022
• Study Start: March 5, 2020
• Primary Completion: December 9, 2020
• Study Completion: December 9, 2020
• Last Updated: February 6, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)