Impact of Home Weight Tele-monitoring on the Number of Office Visits in the First Six Weeks of Life in Infants.

NCT04985227 | Completed

• 1 other identifier: 21-583
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Currently American Academy of Pediatrics (AAP) Bright Futures Guideline recommends 2 visits for all healthy term newborn infants in the first 6 weeks of life, first at 3-5 days of life and the second at around a month. However, compliant parents of infants are known to get at least 1-2 extra visits due to primary care provider's concern about appropriate weight gain. These weight check visits as they take up extra time, car gas, parking charges, loss of work time and paying for childcare during the visits. Clinic resources are also unnecessarily utilized. Remote home monitoring of infant weights with the use of technology could reduce the need for office visits and improve efficiency on the provider side, enhance parental satisfaction and decrease transmission of viruses in the winter season. The main objective is to monitor the daily weight of term infants born at 37 completed weeks of greater, discharged from the newborn nursery, remotely through the electronic medical record by the primary care provider and to reduce any extra visit in the first six weeks of life. Using block randomization, the infants will be assigned to either group A, where no home telemonitoring of weight will take place or group B, where the parent will be provided with a weighing scale. The parent will enter the weight into the MyChart application on the smartphone or on the computer which will be tracked by the pediatrician. The pediatrician will take the decision whether to bring the infant in for a weight check visit based on the weight information. If the weight gain is satisfactory, the pediatrician will see the patient at around 1 month of age per recommendation and the parents will stop the weight checks at that time. The sample size required was 16 on each arm (total 32) which has been increased to 20 each arm to account for technical problems and/or loss to follow up.

Conditions

Failure to Thrive; Newborn Morbidity

Outcome Measures

Primary Outcomes (1)

• Number of visits

  Number of visits to the Primary Care providers office in the first month of life

  1 month

Study Arms (2)

Home weight monitoring

EXPERIMENTAL

Weighing scales will be provided to the parents to weigh their infant and enter the weight daily during the weekdays into the patient portal.

Other: Home weight monitoring

Control

NO INTERVENTION

The parents will visit their Primary Care office in the usual manner as recommended by their Pediatrician.

Interventions

Home weight monitoring OTHER

Parents will be provided with weighing scales to weigh their infant at home and plug in the weight in the patient portal for review by their primary care provider.

Home weight monitoring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Born at Fairview Hospital and discharged from the newborn nursery
• Gestation of 37 weeks and 0 days or greater and weight appropriate for gestation age
• Weight loss is within the range of normal per standard guidelines for the postnatal day (need to elaborate)
• Parents who agree to download the patient portal application of Cleveland Clinic and have access to the infant's information on it.

You may not qualify if:

• Admitted to the NICU after birth
• Congenital malformations or complex health care issues requiring outpatient monitoring by any other provider other than the pediatrician.
• History of drug abuse in mother
• Twin or triplet birth
• Mother does not speak English

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Academy of Pediatrics: collaborator

Study Sites (1)

Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Related Publications (2)

• DiTomasso D, Roberts M, Parker Cotton B. Postpartum Mothers' Experiences With Newborn Weight Checks in the Home. J Perinat Neonatal Nurs. 2018 Oct/Dec;32(4):333-340. doi: 10.1097/JPN.0000000000000367.

  PMID: 30216202 BACKGROUND

• DiTomasso D, Ferszt G. Mothers' Thoughts and Feelings About Using a Pediatric Scale in the Home to Monitor Weight Changes in Breastfed Newborns. Nurs Womens Health. 2018 Dec;22(6):463-470. doi: 10.1016/j.nwh.2018.10.004. Epub 2018 Oct 30.

  PMID: 30389281 BACKGROUND

Related Links

• AAP Bright futures periodicity schedule

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anirudha Das

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Randomized controlled Trial. One group has no intervention. Second group will be provided with a weighing scale and ask to report the infant's weight back to the provider.

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 2, 2021
• Study Start: August 9, 2021
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

US (1)