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

Primary Purpose

Fluid Loss, Dehydration, Extreme Immaturity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sterile water application
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fluid Loss focused on measuring ELBW, premature, neonate, skin, water loss

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The George Washington University Hospital NICU

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Water wash

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Daily fluid intake (ml/kg/day)
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
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)
Incidence of significant PDA
Defined as PDA requiring treatment either medical or surgical
Incidence of NEC
Necrotizing Enterocolitis (NEC): defined as stages II or III
Incidence of BPD
Bronchopulmonary dysplasia (BPD), defined as O2 requirement at 36 weeks post menstrual age (PMA)
Length of stay (days)
Incidence of culture proved sepsis
Culture proved sepsis
Incidence of change in microbiological skin colonization
Change in microbiological skin colonization by skin swab between day one and day 7 of life.

Full Information

First Posted
January 24, 2014
Last Updated
January 18, 2018
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT02052284
Brief Title
The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants
Official Title
The Application of Sterile Water to the Skin of Extremely Low Birth Weight (ELBW) Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fluid Loss, Dehydration, Extreme Immaturity
Keywords
ELBW, premature, neonate, skin, water loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Water wash
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Sterile water application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily fluid intake (ml/kg/day)
Description
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.
Time Frame
First 7 days of life
Secondary Outcome Measure Information:
Title
Skin Score
Description
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
Time Frame
First 7 days of life
Title
Peak total bilirubin (mg/dl)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Title
Incidence of significant PDA
Description
Defined as PDA requiring treatment either medical or surgical
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Title
Incidence of NEC
Description
Necrotizing Enterocolitis (NEC): defined as stages II or III
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Title
Incidence of BPD
Description
Bronchopulmonary dysplasia (BPD), defined as O2 requirement at 36 weeks post menstrual age (PMA)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Title
Length of stay (days)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Title
Incidence of culture proved sepsis
Description
Culture proved sepsis
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Title
Incidence of change in microbiological skin colonization
Description
Change in microbiological skin colonization by skin swab between day one and day 7 of life.
Time Frame
First week of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Extremely Low Birth Weight (less than 1000 grams at birth), and Less than 24 hours of life Exclusion Criteria: Major congenital anomalies Malformations or other surgical emergencies requiring immediate transfer. Major skin abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed El-Dib, MD
Organizational Affiliation
The George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The George Washington University Hospital NICU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7067312
Citation
Baumgart S, Langman CB, Sosulski R, Fox WW, Polin RA. Fluid, electrolyte, and glucose maintenance in the very low birth weight infant. Clin Pediatr (Phila). 1982 Apr;21(4):199-206. doi: 10.1177/000992288202100401.
Results Reference
background
PubMed Identifier
19758381
Citation
Afsar FS. Physiological skin conditions of preterm and term neonates. Clin Exp Dermatol. 2010 Jun;35(4):346-50. doi: 10.1111/j.1365-2230.2009.03562.x. Epub 2009 Sep 15.
Results Reference
background
PubMed Identifier
18253981
Citation
Bell EF, Acarregui MJ. Restricted versus liberal water intake for preventing morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD000503. doi: 10.1002/14651858.CD000503.pub2.
Results Reference
background

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

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