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Completed

NCT Number: NCT05181020

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

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.

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Key information

Conditions

Age range

28 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Connecticut Children's Medical Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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