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

NCT ID: NCT05181020

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2020-12-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Enteral Feeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Maternal Voice Exposure

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Connecticut Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shabnam Lainwala

Principal Investigator, Attending Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shabnam Lainwala, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Connecticut Children's Medical Center

Locations

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Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35982244 (View on PubMed)

Other Identifiers

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20-026

Identifier Type: -

Identifier Source: org_study_id

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