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Improving Lactation Success in Mothers of Critically Infants

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ClinicalTrials.gov Identifier: NCT04097860
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit

Condition or disease Intervention/treatment Phase
Breast Pumping Behavioral: Text message including biomarker of breast pumping adequacy Not Applicable

Detailed Description:
Although compelling evidence exists that breast milk (BM) improves infant health, mothers of critically ill infants frequently produce insufficient amounts BM which is likely due to inadequate daily breast pumping frequency. BM sodium levels are an easy to measure biomarker of pumping frequency and providing this information to mothers via text messaging may increase their pumping frequency and BM production. Therefore, the overall objective of this pilot study is to determine the feasibility and potential benefits of a mHealth intervention to increase BM pumping frequency and BM production in mothers delivering critically ill infants admitted to the neonatal intensive care unit (NICU) at UF Health. Specific aims include (1) evaluate the feasibility of a mHealth intervention to increase BM pumping frequency and BM production and (2) assess whether results indicate a signal of effectiveness supporting a subsequent adequately powered randomized clinical trial (RCT). Following delivery, 50 mothers of critically ill infants admitted to the NICU will be randomized to one of two groups. The Enhanced Intervention Group will receive text messages including both general lactation information and a personalized message consisting of the mother's BM sodium level, pumping frequency and feedback regarding pumping frequency. The Standard Intervention Group will receive only general lactation information. Results will be used to revise the intervention and study processes and to estimate outcome measurement variability and effect sizes needed for sample size calculations for an adequately powered RCT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Individuals monitoring breast milk production and sodium levels will be blinded
Primary Purpose: Prevention
Official Title: Improving Lactation Success in Mothers of Critically Infants Using Personalized Real-Time Biomarker Based Text Messages
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Intervention group
Will be sent one message that includes general information pertinent to all mothers expressing BM for their infants and one personalized real-time biomarker based message which will include the sodium level contained in the BM since the previous message, the number of times pumped on those days and will either congratulate the participant on how well the is pumping BM for the infant or how many more times per day the participant needs to pump to decrease the BM sodium level and increase BM production
Behavioral: Text message including biomarker of breast pumping adequacy
The intervention group will be sent one message that includes general information pertinent to all mothers expressing BM for their infants and one personalized real-time biomarker based message which will include the sodium level contained in the BM since the previous message, the number of times pumped on those days and will either congratulate the participant on how well the participant is pumping BM for the infant or how many more times per day the participant needs to pump to decrease the BM sodium level and increase BM production

No Intervention: Control group
Will only be sent text messages that include the same general lactation information sent to the treatment group



Primary Outcome Measures :
  1. Volume of breast milk (BM) [ Time Frame: Up to 2 weeks ]
    All BM will be weighed (1 mg of BM = 1 mL) by a BM technician and the weight recorded in the infant's medical record. BM will be weighed on a portable digital scale accurate to within 0.1 grams.


Secondary Outcome Measures :
  1. Number of breast pumping episodes [ Time Frame: Up to 2 weeks ]
    Daily number of pumping sessions as recorded in the mother's log book and verified by examination of the date and time on vials of pumped BM.

  2. Breast milk sodium level [ Time Frame: Up to 2 weeks ]
    Daily BM sodium levels beginning when the mother has produced at least 5mL of BM and continuing for the two week study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • stated intent to provide BM to the infant
  • infant not expected to be stable enough to bottle/breastfeed for > 14 days
  • owns a mobile phone with unrestricted SMS capability.

Exclusion Criteria:

  • known illicit drug use
  • breast reduction or augmentation
  • positive HIV status
  • does not anticipate being able to bring BM to the NICU at least 4X/week
  • infant not expected to live > 7 days following delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097860


Contacts
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Contact: Leslie A Parker, MD 352 215 9360 parkela@ufl.edu

Locations
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United States, Florida
UF Health Children's Hospital Not yet recruiting
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Leslie A Parker, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04097860     History of Changes
Other Study ID Numbers: IRB201902053
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No