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Mobile App Support for Breast Pumping Success
N/A
Waitlist Available
Led By Leslie A Parker, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights
Study Summary
This trial will test a mobile phone app to see if it can help mothers of critically ill infants in the NICU increase their breast milk production.
Who is the study for?
This trial is for mothers who plan to breastfeed their critically ill infants in the NICU and can't start bottle/breastfeeding within 14 days. They must own a mobile phone with text messaging, speak English, and be able to deliver milk to the NICU at least four times weekly. Mothers with drug use, breast surgery history, HIV, or those whose infants may not survive past one week are excluded.Check my eligibility
What is being tested?
The study tests whether sending text messages that include biomarkers of adequate breast pumping can help increase the frequency of pumping and overall breast milk production for mothers of critically ill newborns.See study design
What are the potential side effects?
Since this intervention involves receiving informational text messages rather than medication or medical procedures, there are no direct physical side effects expected from participating in this clinical trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Volume of breast milk (BM)
Secondary outcome measures
Breast milk sodium level
Number of breast pumping episodes
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
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
Group II: Control groupActive Control1 Intervention
Will only be sent text messages that include the same general lactation information sent to the treatment group
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,583 Total Patients Enrolled
Leslie A Parker, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I have had breast surgery to change size.You plan to breastfeed your baby.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently partaking in this medical study?
"Affirmative. Clinicaltrials.gov's data indicates that recruitment for this trial is in full swing, having initially been published on December 1st 2020 and recently edited as of September 13th 2022. The study requires 170 patients to be enrolled across a single site."
Answered by AI
Is the recruitment process for this study still underway?
"Affirmative. Clinicaltrials.gov hosts evidence that this trial, which was posted on December 1st 2020, is presently searching for participants to join the study. 170 individuals are needed from one medical centre."
Answered by AI
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