Early Versus Delayed Cord Clamping at Term: Neurodevelopmental Outcomes in Swedish Infants at 4 Years of Age

NCT01581489 | Completed

• 1 other identifier: NATIBAR1213
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared to early clamping, a delay in clamping in clamping of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight to the newborn infant. The results of previous intervention studies on delayed clamping are mixed, and few have followed the infants beyond the perinatal period. All longer follow up studies have been performed in low income countries except for the investigators earlier study, showing less iron deficiency and improved iron stores after delayed cord clamping at 4 months of age. The main objective of the current study is to assess whether the time of cord clamping affects neurodevelopment at 4 years of age in a large sample of full-term, Swedish infants. The investigators hypothesis is that as delayed cord clamping improves iron stores at 4 months, this could affect the child's development positively.

Conditions

Developmental Delay; Iron Deficiency

Keywords

Cord clamping; iron deficiency; Neurodevelopment

Outcome Measures

Primary Outcomes (1)

• Intelligence quotient (IQ) as measured by the Wechsler Preschool and Primary Scale of Intelligence-III.

  The Wechsler Preschool and Primary Scale of Intelligence (WPPSI) is an intelligence test designed for children ages 2 years 6 months to 7 years 3 months. A trained and experienced psychologist will perform the test and do the evaluation.

  48 months (plus 3 months)

Secondary Outcomes (6)

• Score of the different subsets of Wechsler Preschool and Primary Scale of Intelligence-III.

  48 months (plus 3 months)

• Psychomotor development assessed by the Ages and Stages Questionnaire.

  48 months (plus 3 months)

• Fine motor skills assessed by the Movement Assessment Battery for Children-Second Edition.

  48 months (plus 3 months)

• Behaviour assessed by the Strengths and Difficulties Questionnaire or it's subscales.

  48 months (plus 3 months)

• Gender effect on the result of the developmental tests.

  48 months (plus 3 months)

Study Arms (2)

Early cord clamping (ECC)

Early cord clamping consisted of early (=\< 10 s) clamping of the umbilical cord at birth.

Procedure: Time to clamping of the umbilical cord after delivery

Delayed cord clamping (DCC)

Delayed cord clamping consisted of delayed (\>= 180 s) clamping of the umbilical cord at birth.

Procedure: Time to clamping of the umbilical cord after delivery

Interventions

Time to clamping of the umbilical cord after delivery PROCEDURE

The time after delivery of the newborn until the midwife stops the circulation in the umbilical cord with a clamp.

Also known as: Immediate cord clamping, Late cord clamping, Deferred cord clamping

Delayed cord clamping (DCC); Early cord clamping (ECC)

Eligibility Criteria

• Age: 48 Months - 51 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The eligble population consists of a group of 382 children who were included in a trial (NCT01245296) and randomized to either early or delayed cord clamping. The parents will be asked for consent for their child to participate in the current follow up study.

You may qualify if:

• Participant in the earlier cord clamping trial
• Age between 48 and 51 months

Sponsors & Collaborators

• Uppsala University: lead
• Umeå University: collaborator
• Halmstad County Hospital: collaborator
• County Council of Halland, Sweden: collaborator

Study Sites (1)

Hospital of Halland, Halmstad

Halmstad, Halland County, 301 85, Sweden

Location

Related Publications (2)

• Andersson O, Hellstrom-Westas L, Andersson D, Domellof M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157. doi: 10.1136/bmj.d7157.

  PMID: 22089242 BACKGROUND

• Andersson O, Lindquist B, Lindgren M, Stjernqvist K, Domellof M, Hellstrom-Westas L. Effect of Delayed Cord Clamping on Neurodevelopment at 4 Years of Age: A Randomized Clinical Trial. JAMA Pediatr. 2015 Jul;169(7):631-8. doi: 10.1001/jamapediatrics.2015.0358.

  PMID: 26010418 RESULT

MeSH Terms

Conditions

Learning Disabilities; Iron Deficiencies

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ola Andersson, MD

  Hospital of Halland, Halmstad

  PRINCIPAL INVESTIGATOR

• Barbro Lindquist, PhD

  Hospital of Halland, Halmstad

  PRINCIPAL INVESTIGATOR

• Lena Hellström-Westas, Professor

  Uppsala University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

SE (1)