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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Maternal Voice | No Intervention | Maternal voice delivered to infant in arm 1 by spoken words or recording. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Oral Feedings | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shabnam Lainwala, MBBS, PhD | Connecticut Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35982244 | Result | 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. |
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Only infants were considered enrolled in the study
Subjects enrolled in Open bay NICU between 6/1/2020 and 9/30/2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Oral Feedings | 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. | The difference in proportion of feeds from baseline feeds to Intervention feeds and Follow-up feeds was calculated. | Posted | Mean | Standard Deviation | proportion of feeds | 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. |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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There were no limitations to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shabnam Lainwala, MD Neonatologist | Connecticut Children's Medical Center | 8605458950 | slainwala@connecticutchildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2020 | Mar 5, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2019 | Oct 29, 2025 | ICF_001.pdf |
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| weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| 0 |
| 25 |
| 0 |
| 25 |
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| 25 |
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