Trial record 10 of 199 for:    Open Studies | "Drinking Water"

The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by George Washington University
Sponsor:
Information provided by (Responsible Party):
Mohamed ElDib, George Washington University
ClinicalTrials.gov Identifier:
NCT02052284
First received: January 24, 2014
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

Extremely low birth weight infants have significant water loss through their skin immediately after birth. This significant fluid loss is because they have large amounts of fluids, have immature skin and large surface area. Loss of fluids is associated with many complications. The investigators hypothesize that application of sterile water to the skin of these infants is associated with decreased fluid requirements in the first week of life , improve skin integrity and decrease some complications of prematurity.


Condition Intervention
Fluid Loss
Dehydration
Extreme Immaturity
Other: Sterile water application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Daily fluid intake (ml/kg/day) [ Time Frame: First 7 days of life ] [ Designated as safety issue: No ]
    The primary outcome is daily fluid requirements in the first week of life. Daily fluid requirements from Day1 to Day7 will be compared between intervention and control groups.


Secondary Outcome Measures:
  • Skin Score [ Time Frame: First 7 days of life ] [ Designated as safety issue: No ]
    Neonatal Skin Condition Scale (NSCS) is a validated skin score used in the Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) and the National Association of Neonatal Nurses (NANN) neonatal skin care evidence-based practice project. Score ranges from 3 to 9, with 9 being the worse

  • Peak total bilirubin (mg/dl) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of significant PDA [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks ] [ Designated as safety issue: No ]
    Defined as PDA requiring treatment either medical or surgical

  • Incidence of NEC [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks ] [ Designated as safety issue: No ]
    Necrotizing Enterocolitis (NEC): defined as stages II or III

  • Incidence of BPD [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks ] [ Designated as safety issue: No ]
    Bronchopulmonary dysplasia (BPD), defined as O2 requirement at 36 weeks post menstrual age (PMA)

  • Length of stay (days) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of culture proved sepsis [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 16 weeks ] [ Designated as safety issue: No ]
    Culture proved sepsis

  • Incidence of change in microbiological skin colonization [ Time Frame: First week of life ] [ Designated as safety issue: No ]
    Change in microbiological skin colonization by skin swab between day one and day 7 of life.


Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
The control group will receive standard skin care of the NICU, which does not include specific measures to modulate skin-barrier function.The current practice at GWUH NICU is that nurses clean the bodies of newborns less than 1000 grams using a piece of damp cloth with warm water. This is performed at birth and consequently every other days.
Experimental: Water wash
The study group will undergo a protocol of sterile water application in addition to routine skin care of the NICU. The study group will receive more frequent and standardized applications. A commercially sterile water bottle (Enfamil® Water) will be kept inside the isolette, to be maintained at isolette temperature, and will be changed on a daily basis. Nurses use sterile gloves as a routine for care of ELBW infants. A 2 inches x 2 inches sterile gauze will be soaked in sterile water and gently applied to all skin of the baby excluding umbilical cord and IV lines sites. This procedure will be repeated every 4 hours with routine patient care for the first 1 week of life.
Other: Sterile water application
Nurses are trained in proper dispensing and application of water in a sterile gentle way that will minimize shear force on the skin, risk for skin injury, and the potential for spread of fecal flora.

Detailed Description:

Extremely low birth weight (ELBW) infants have significant transepidermal water loss immediately after birth. This significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. Water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. In order to compensate for these losses, clinicians have to progressively increase fluid intake. Excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (PDA), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and mortality. Also skin integrity is important to protect against skin infection and secondary sepsis. Based on recent studies and relevant data, the risk of sepsis in ELBW is up to 40% nationwide, but only about 25% at GWUH Water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. The current practice at GWUH is to clean the bodies of premature infants using a piece of damp cloth with warm water. This is performed at birth and consequently every other days. The study group will receive more frequent and standardized applications. The investigators hypothesize that application of sterile water in ELBW infants is associated with decreased fluid requirements in the first week of life. As a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of BPD with no increased incidence of skin or systemic infections.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Extremely Low Birth Weight (less than 1000 grams at birth), and
  2. Less than 24 hours of life

Exclusion Criteria:

  1. Major congenital anomalies
  2. Malformations or other surgical emergencies requiring immediate transfer.
  3. Major skin abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052284

Contacts
Contact: Mohamed El-Dib, MD 202-715-5236 meldib@mfa.gwu.edu

Locations
United States, District of Columbia
The George Washington University Hospital NICU Recruiting
Washington, District of Columbia, United States, 20037
Contact: Mohamed El-Dib, MD    202-715-5236    meldib@mfa.gwu.edu   
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Mohamed El-Dib, MD The George Washington University
  More Information

Publications:
Responsible Party: Mohamed ElDib, Assistant Professor of Pediatrics and of Neurology, George Washington University
ClinicalTrials.gov Identifier: NCT02052284     History of Changes
Other Study ID Numbers: 071319
Study First Received: January 24, 2014
Last Updated: January 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
ELBW
premature
neonate
skin
water loss

Additional relevant MeSH terms:
Birth Weight
Dehydration
Body Weight
Signs and Symptoms
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2014