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

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052284
• Other study ID #: 071319
• Status: Completed
• Phase: N/A
• First received: January 24, 2014
• Last updated: January 18, 2018
• Start date: January 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Dehydration
• Extreme Immaturity
• Fluid Loss

Intervention

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.

Locations

Country	Name	City	State
United States	The George Washington University Hospital NICU	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2014;12:CD000503. — View Citation

Outcome

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