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

Not Applicable

Completed

• Conditions: Extreme Immaturity; Fluid Loss; Dehydration
• Interventions: Other: Sterile water application

• Registration Number: NCT02052284
• Lead Sponsor: George Washington University

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-31
• Study First Posted: 2014-02-03
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-31
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water wash	Sterile water application	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.

Primary Outcome Measures

Name	Time	Method
Daily fluid intake (ml/kg/day)	First 7 days of life	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

Name	Time	Method
Peak total bilirubin (mg/dl)	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Incidence of significant PDA	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks	Defined as PDA requiring treatment either medical or surgical
Incidence of NEC	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks	Necrotizing Enterocolitis (NEC): defined as stages II or III
Incidence of BPD	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks	Bronchopulmonary dysplasia (BPD), defined as O2 requirement at 36 weeks post menstrual age (PMA)
Length of stay (days)	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks
Incidence of change in microbiological skin colonization	First week of life	Change in microbiological skin colonization by skin swab between day one and day 7 of life.
Skin Score	First 7 days of life	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
Incidence of culture proved sepsis	Participants will be followed for the duration of hospital stay, an expected average of 16 weeks	Culture proved sepsis

Trial Locations

Locations (1)

The George Washington University Hospital NICU; 🇺🇸 Washington, District of Columbia, United States