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

Sponsor
Connecticut Children's Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05181020
Collaborator
(none)
25
1
1
33.9
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Maternal Voice Exposure
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants
Actual Study Start Date :
Mar 5, 2020
Actual Primary Completion Date :
Jun 30, 2020
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Oral feeding volume [Through study completion, average 40 weeks post menstrual age]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Weeks to 40 Weeks
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Connecticut Children's Medical Center Hartford Connecticut United States 06106

Sponsors and Collaborators

  • Connecticut Children's Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shabnam Lainwala, Principal Investigator, Attending Neonatologist, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT05181020
Other Study ID Numbers:
  • ConnecticutCMC
First Posted:
Jan 6, 2022
Last Update Posted:
Jan 6, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shabnam Lainwala, Principal Investigator, Attending Neonatologist, Connecticut Children's Medical Center

Study Results

No Results Posted as of Jan 6, 2022