Breast Milk vs Sucrose in Relieving Procedural Pain in Preterm Neonates During Blood Draw by Automated Heel Lance

NCT04898881 | Completed Phase 4

• 1 other identifier: 1905002251
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Skin breaking procedure through an automated heel lancet for blood draws is a common painful procedure in the Neonatal Intensive care unit (NICU). Recurrent pain in preterm neonates is associated with long-term complications. The primary objective of the study is to compare pain scores between two groups (24% sucrose and breast milk) during blood draw using an automated heel lancet in preterm neonates. The investigator conducted a prospective randomized controlled trial in preterm neonates, to compare the pain scores in infants receiving either breast milk or sucrose. Premature Infant pain profile- Revised pain profile is used to assign pain scores. The primary outcome measure is the comparison of pain scores between the two groups.

Conditions

Pain

Keywords

Pain management in preterm neonates

Outcome Measures

Primary Outcomes (1)

• Pain Profile

  Premature Infant Pain Profile- Revised pain profile is used to give pain scores to the participants. Minimum score and maximum scores on the scale are zero and twenty one. The pain scores increases with increasing severity of pain.

  During the Procedure

Secondary Outcomes (1)

• Pain Profile

  Pain scores will be given at 30 seconds interval for 2 minutes, post-procedure

Study Arms (2)

Breast Milk

ACTIVE COMPARATOR

2 ml of Breast milk given one time, two minutes prior to the heel lance

Other: Breast Human Milk

24 %Sucrose

OTHER

0.5 ml sucrose to be given once, two minutes prior to the heel lance

Other: 24 % Sucrose

Interventions

Breast Human Milk OTHER

Interventional drug is given to the neonates 2 minutes before the heel lance

Breast Milk

24 % Sucrose OTHER

0.5 ml of sucrose given once 2 minutes prior to procedure

24 %Sucrose

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All Infants with gestational age between 30 1/7 and 36 6/7 weeks
• Within 30 days of post-natal life
• Breast milk is available for the neonate
• Scheduled for a blood draw

You may not qualify if:

• Neonates on intravenous or peroral medications for sedation/analgesia or anti-epileptics
• Infants diagnosed with neonatal abstinence syndrome and neonatal encephalopathy
• Infants who are critically ill, on assisted ventilation \> 2L HFNC and on ionotropic support
• Infants with major congenital abnormalities/dysmorphism

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Detroit Medical center

Detroit, Michigan, 48201, United States

Location

Related Publications (7)

• Sener Taplak A, Erdem E. A Comparison of Breast Milk and Sucrose in Reducing Neonatal Pain During Eye Exam for Retinopathy of Prematurity. Breastfeed Med. 2017 Jun;12:305-310. doi: 10.1089/bfm.2016.0122. Epub 2017 Apr 17.

  PMID: 28414522 BACKGROUND

• Shah PS, Herbozo C, Aliwalas LL, Shah VS. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004950. doi: 10.1002/14651858.CD004950.pub3.

  PMID: 23235618 BACKGROUND

• Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.

  PMID: 22392168 BACKGROUND

• Corrigendum to "Analgesic Effect of Maternal Human Milk Odor on Premature Neonates: A Randomized Controlled Trial". J Hum Lact. 2017 Nov;33(4):822. doi: 10.1177/0890334417733738.

  PMID: 28984527 BACKGROUND

• Badiee Z, Asghari M, Mohammadizadeh M. The calming effect of maternal breast milk odor on premature infants. Pediatr Neonatol. 2013 Oct;54(5):322-5. doi: 10.1016/j.pedneo.2013.04.004. Epub 2013 May 23.

  PMID: 23707040 BACKGROUND

• Blass EM. Milk-induced hypoalgesia in human newborns. Pediatrics. 1997 Jun;99(6):825-9. doi: 10.1542/peds.99.6.825.

  PMID: 9164777 BACKGROUND

• Velumula PK, Elbakoush F, Tabb C 2nd, Farooqi A, Lulic-Botica M, Jani S, Natarajan G, Bajaj M. Breast milk vs 24% sucrose for procedural pain relief in preterm neonates: a non-inferiority randomized controlled trial. J Perinatol. 2022 Jul;42(7):914-919. doi: 10.1038/s41372-022-01352-2. Epub 2022 Feb 23.

  PMID: 35197549 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Milk, Human; Sucrose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Pradeep Velumula, MD

  Detroit Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Neonatal-Perinatal Medicine

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 24, 2021
• Study Start: January 1, 2020
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

US (1)